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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision.
Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.
entered elsewhere
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Arm | Experimental | PrEP (pre-exposure prophylaxis) provision, STI screening and treatment, GAHT (gender-affirming hormonal therapy), peer-health management using strengths-based management. PrEP provision includes using one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil. |
|
| Deferred Intervention Arm | Experimental | 0-6 months PrEP (pre-exposure prophylaxis) provision and STI screening and treatment. From months 6-18, GAHT (gender-affirming hormonal therapy) and peer-health management using strengths-based management. PrEP provision includes one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily table of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Intervention Arm | Drug | Truvada, Descovy in the United States; Truvada in Brazil |
|
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Uptake | Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date. | 0-18 months |
| PrEP Adherence | Self-reported adherence to daily PrEP by study visit | 0-18 months |
| Acceptability and Feasibility of Co-located Services | Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits. | 0-18 months |
| Participant Retention at Weeks 26, 52 and 78 | Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit. | Weeks 26, 52, 78 |
| Acceptability and Feasibility of Peer Health Navigation | The average number of peer health navigator encounters. | 0-18 months |
| Acceptability and Feasibility of Peer Health Navigation | Number of each type of peer health navigation encounter. | 0-18 months |
| Acceptability and Feasibility of Co-located Services | Percentage of participants who report desire for co-located services at the end of the study | 0-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Examining Changes in Sexual Risk-taking Behavior | Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78. | 0-18 months |
| Examining Changes in Sexual Risk-taking Behavior |
Not provided
Inclusion Criteria:
TGW (assigned male at birth, trans-feminine spectrum - as defined in the SSP Manual - by self-report) who meet all of the following criteria are eligible for inclusion in this study.
Eighteen years or older at the time of screening.
Willing and able to provide informed consent for the study.
Interest in PrEP - as defined in the SSP Manual.
Non-reactive HIV test results at Screening and Enrollment.
Available to return for all study visits and within site catchment area, as defined per site's Standard Operating Procedures (SOP).
At risk for sexually acquiring HIV infection based on self-report of at least one of the following:
Willing to undergo all required study procedures.
General good health, as evidenced by the following laboratory values:
Note: Otherwise eligible participants with laboratory results outside the above-mentioned values, with the exception of those with reactive HIV test, can be re-tested during the screening window. Participants with reactive HIV tests will not be able to rescreen.
Note: Participants who practice receptive vaginal sex cannot be provided Descovy® as it is not approved for this indication.
Exclusion Criteria:
Transgender Women
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| Name | Affiliation | Role |
|---|---|---|
| Tonia Poteat, PhD, MPH | UNC Chapel Hill | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridge HIV CRS | San Francisco | California | 94102 | United States | ||
| Harlem Prevention Center CRS |
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All enrolled participants were randomized to study arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention Arm | PrEP, GAHT and peer-health management was provided from enrollment to study exit. |
| FG001 | Deferred Intervention Arm | PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population is the same as the assignment in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention Arm | PrEP, GAHT and peer-health management was provided from enrollment to study exit. |
| BG001 | Deferred Intervention Arm | PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PrEP Uptake | Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date. | Limited to participants who obtained PrEP at the study clinic | Posted | Mean | Standard Deviation | days | 0-18 months |
|
From enrollment until end of follow-up (0-18 months)
Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Intervention Arm | PrEP, GAHT and peer-health management was provided from enrollment to study exit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| HPTN Statistical Manager | HPTN Statistical & Data Management Center | 206-667-4004 | HPTN-Data-Access@scharp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 13, 2020 | Jul 21, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000613801 | emtricitabine tenofovir alafenamide |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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Intermediate Intervention Arm vs. Deferred Intervention Arm
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| Deferred Intervention Arm | Drug | Truvada, Descovy in the United States; Truvada in Brazil |
|
|
| PrEP Adherence |
The average number of days to first PrEP permanent discontinuation. |
| 0-18 months |
| PrEP Adherence | The median number of days to first PrEP permanent discontinuation. | 0-18 months |
| PrEP Adherence | Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation. | 0-18 months |
| PrEP Adherence | Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation. | 0-18 months |
| PrEP Adherence | The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample. | Week 26 |
| PrEP Persistent | PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point. | 0-18 months |
| PrEP Uptake | Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic.. | Week 26 |
Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.
| 0-18 months |
| Examining Changes in Sexual Risk-taking Behavior | Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78. | 0-18 months |
| Examining Changes in Sexual Risk-taking Behavior | Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78. | 0-18 months |
| Prevalence of STI Infection (GC, CT, Syphilis) at Baseline | To determine baseline prevalence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) by study arm | 0 months |
| Estimate Prevalence of Baseline Laboratory Values. | To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions. | 0 months |
| Gender-Affirming Hormone Therapy by Visit | Taken hormones for gender identity/transition | 0-18 months |
| Gender-Affirming Hormone Therapy by Visit | Currently taking hormones for gender identity/transition | 0-18 months |
| Gender-Affirming Hormone Therapy by Visit | Where do you currently get your hormones? | 0-18 months |
| Gender-Affirming Hormone Therapy by Visit | Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly | 0-18 months |
| Gender-Affirming Hormone Therapy by Visit | Ever had breast augmentation/surgery | 0-18 months |
| Gender-Affirming Hormone Therapy by Visit | Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS | 0-18 months |
| Annual Incidence of HIV Infections | The number of incident HIV infections at each time point by arm. Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39. | 0-18 months |
| Incidence of STI Infection (GC, CT, Syphilis) | To determine annual incidence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm. | 0-18 months |
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake | PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle. | 0-18 months |
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits. | The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits. | 0-18 months |
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence | PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table. | 0-18 months |
| Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research | An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table. | 0-18 months |
| New York |
| New York |
| 10027 |
| United States |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | United States |
| Instituto de Pesquisa Clinicaq Evandro Chagas CRS | Manguinhos | Rio de Janeiro | 221045-900 | Brazil |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| One or more reactive HIV test results or acute HIV infection suspected |
|
| Participant refused further participation |
|
| Participant unable to adhere to visit schedule |
|
| Other reasons |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Age (in years) dichotomized as 25 and below, and 26 and above. | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PrEP Adherence | Self-reported adherence to daily PrEP by study visit | Number of participants who completed CASI at each study visit. Due to missingness, this number may be lower than the number of participants enrolled in the study. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Primary | Acceptability and Feasibility of Co-located Services | Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits. | Enrolled participants. Deferred arm participants receive co-located services at 6 months. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Primary | Participant Retention at Weeks 26, 52 and 78 | Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit. | The denominators in the table differ from the overall number analyzed because the denominator excludes any participants who have terminated from the study or seroconverted at the time of the visit. | Posted | Count of Participants | Participants | Weeks 26, 52, 78 |
|
|
|
| Primary | Acceptability and Feasibility of Peer Health Navigation | The average number of peer health navigator encounters. | Enrolled population | Posted | Mean | Standard Deviation | encounters | 0-18 months |
|
|
|
| Primary | Acceptability and Feasibility of Peer Health Navigation | Number of each type of peer health navigation encounter. | Total number of peer health navigation encounters by arm. | Posted | Count of Units | Encounters | 0-18 months | Encounters | Encounters |
|
|
|
| Primary | Acceptability and Feasibility of Co-located Services | Percentage of participants who report desire for co-located services at the end of the study | Participants with a non-missing response to the CASI question concerning desire for co-located services at the end of the study. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
|
| Primary | PrEP Adherence | The average number of days to first PrEP permanent discontinuation. | Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination. | Posted | Mean | Standard Deviation | days | 0-18 months |
|
|
|
| Primary | PrEP Adherence | The median number of days to first PrEP permanent discontinuation. | Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination. | Posted | Median | Inter-Quartile Range | days | 0-18 months |
|
|
|
| Primary | PrEP Adherence | Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation. | TFVDP levels of participants who obtained PrEP at the study clinic. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Primary | PrEP Adherence | Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation. | FTC-TP levels of participants who obtained PrEP at the study clinic. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Primary | PrEP Adherence | The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample. | Participants who obtained PrEP at the study clinic. | Posted | Count of Participants | Participants | Week 26 |
|
|
|
|
| Primary | PrEP Persistent | PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point. | Participants who obtained PrEP at the study clinic. | Posted | Mean | Standard Deviation | percent of visits | 0-18 months |
|
|
|
| Primary | PrEP Uptake | Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic.. | Posted | Count of Participants | Participants | Week 26 |
|
|
|
|
| Secondary | Examining Changes in Sexual Risk-taking Behavior | Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78. | The numbers presented in "Overall Number of Participants Analyzed" represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions "condom use with HIV+ people" and "condom use with HIV unknown people" analyses were restricted to participants who completed the CASI questionnaire at that visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Examining Changes in Sexual Risk-taking Behavior | Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78. | The numbers presented in "Overall Number of Participants Analyzed" represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions "condom use with HIV+ people" and "condom use with HIV unknown people" analyses were restricted to participants who completed the CASI questionnaire at that visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Examining Changes in Sexual Risk-taking Behavior | Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78. | Number of participants who completed CASI questionnaire per visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Examining Changes in Sexual Risk-taking Behavior | Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78. | Number of participants who completed CASI questionnaire per visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Prevalence of STI Infection (GC, CT, Syphilis) at Baseline | To determine baseline prevalence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) by study arm | Enrolled participants | Posted | Count of Participants | Participants | 0 months |
|
|
|
|
| Secondary | Estimate Prevalence of Baseline Laboratory Values. | To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions. | Enrolled participants. There is insufficient data (below the lower limit of quantification) to perform valid logistic regression modelling on participants with Hepatitis B or renal insufficiency at baseline. | Posted | Count of Participants | Participants | 0 months |
|
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Taken hormones for gender identity/transition | Number of participants who completed the CASI form at each study visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Currently taking hormones for gender identity/transition | Number of participants who completed the CASI form at each study visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Where do you currently get your hormones? | Number of participants who reported they were currently taking hormones. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly | Number of participants who completed the CASI form at each study visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Ever had breast augmentation/surgery | Number of participants who completed the CASI form at each study visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Gender-Affirming Hormone Therapy by Visit | Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS | Number of participants who completed the CASI form at each study visit. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
| Secondary | Annual Incidence of HIV Infections | The number of incident HIV infections at each time point by arm. Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39. | Enrolled participants | Posted | Number | participants | 0-18 months |
|
|
|
|
| Secondary | Incidence of STI Infection (GC, CT, Syphilis) | To determine annual incidence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm. | Enrolled participants | Posted | Number | participants | 0-18 months |
|
|
|
|
| Secondary | Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake | PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
|
| Secondary | Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits. | The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits. | A total of 268 participants initiated PrEP at the study clinic. High PrEP adherence was assessed across 1,533 study visits. | Posted | Count of Units | Visits | 0-18 months | Visits | Visits |
|
|
|
|
| Secondary | Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence | PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS): Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table. | Participants who obtained PrEP at the study clinic. | Posted | Mean | Standard Error | Percentage of Visits | 0-18 months |
|
|
|
|
| Secondary | Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research | An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table. | All enrolled participants. | Posted | Count of Participants | Participants | 0-18 months |
|
|
|
|
| 2 |
| 149 |
| 13 |
| 149 |
| 25 |
| 149 |
| EG001 | Deferred Intervention Arm (0-6 Months) | PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit. | 0 | 155 | 3 | 155 | 12 | 155 |
| EG002 | Deferred Intervention Arm (6-18 Months) | PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit. | 0 | 155 | 3 | 155 | 18 | 155 |
| Acute abdomen | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Nosocomial infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| 2-3 doses per week |
|
| 4-6 doses per week |
|
| 7 doses per week |
|
| Missing |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 26 |
|
| Week 39 |
|
| Week 52 |
|
| Week 65 |
|
| Week 78 |
|
| Week 52 |
|
|
| Week 78 |
|
|
| Text |
|
| Phone |
|
| Video encounter |
|
| 0.80 |
| Percentage |
| 71.81 |
| 2-Sided |
| 95 |
| 64.59 |
| 79.04 |
The estimates and C.I. (In percentage) are derived using Chi-squared test. |
| Superiority |
| Less than 2 doses per week |
|
| 2-3 doses per week |
|
| 4-6 doses per week |
|
| 7 doses per week |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| 0.6381 |
| Percentage |
| 87.10 |
| 2-Sided |
| 95 |
| 81.82 |
| 92.37 |
The estimates and C.I. (In percentage) are derived using binomial distribution. |
| Other |
| No sex |
|
| Oral sex only |
|
| I did not have sex with anyone whom I knew was HIV+ |
|
| None of the time |
|
| Less than half the time |
|
| About half the time |
|
| More than half the time |
|
| All of the time |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| No sex |
|
| Oral sex only |
|
| No sex with anyone whose HIV status was unknown |
|
| None of the time |
|
| Less than half the time |
|
| About half the time |
|
| More than half of the time |
|
| All of the time |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| No sex |
|
| Oral sex only |
|
| None of the time |
|
| Less than half the time |
|
| About half the time |
|
| More than half of the time |
|
| All of the time |
|
| Prefer not to answer |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| No |
|
| Yes |
|
| Prefer not to answer |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Syphilis (Positive/Reactive) |
|
Calculating the odds of Chlamydia Trachomatis.
| Regression, Logistic |
| 0.91 |
| Odds Ratio (OR) |
| 0.96 |
| 2-Sided |
| 95 |
| 0.45 |
| 2.03 |
| Other |
The odds ratio was calculated with the deferred intervention arm as the reference group. |
| Calculating the odds of a syphilis positive/reactive test. | Regression, Logistic | 0.32 | Odds Ratio (OR) | 0.76 | 2-Sided | 95 | 0.45 | 1.30 | Other | The odds ratio was calculated with the deferred intervention arm as the reference group. |
| Renal Insufficiency |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Only from medical providers |
|
| Medical providers and from friends, online, or other sources |
|
| Only from friends, online, or other non-licensed sources |
|
| Some other source |
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 13 |
|
|
| Week 26 |
|
|
| Week 39 |
|
|
| Week 52 |
|
|
| Week 65 |
|
|
| Week 78 |
|
|
| Week 26 |
|
| Week 39 |
|
| Week 52 |
|
| Week 65 |
|
| Week 78 |
|
| Incidence Rate |
| 0.48 |
| 2-Sided |
| 95 |
| 0.07 |
| 3.39 |
| Superiority |
| Week 26 |
|
| Week 39 |
|
| Week 52 |
|
| Week 65 |
|
| Week 78 |
|
Incidence rate of STIs for deferred intervention arm
| Poisson Regression |
| 0.93 |
| Incidence Rate |
| 32.01 |
| 2-Sided |
| 95 |
| 23.92 |
| 42.83 |
Incidence Rate of any STI Incidence per Person-Years using Poisson Regression was calculated. |
| Superiority |
| Poisson regression was used to compare the incidence rate of STIs by arm. | Poisson Regression | 0.93 | Poisson Regression | 31.74 | 2-Sided | 95 | 25.96 | 38.80 | Incidence Rate of any STI Incidence per Person-Years using Poisson Regression was calculated. | Superiority |
| Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education. | Regression, Logistic | 0.37 | Odds Ratio (OR) | 0.38 | 2-Sided | 95 | 0.05 | 3.16 | Estimates are for comparison of highest level of education primary school vs. college. | Superiority |
| Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education. | Regression, Logistic | 0.04 | Odds Ratio (OR) | 0.41 | 2-Sided | 95 | 0.17 | 0.98 | Estimates are for comparison of highest level of education high school vs. college | Superiority |
| Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for physical violence. | Regression, Logistic | 0.07 | Odds Ratio (OR) | 2.21 | 2-Sided | 95 | 0.98 | 5.28 | Estimates are for comparison of physical violence yes vs. no | Superiority |
| Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304).This section provides p-values and odds ratio estimates for physical violence. | Regression, Logistic | 0.97 | Odds Ratio (OR) | 999.99 | 2-Sided | 95 | 0.001 | 999.99 | Estimates are for comparison of physical violence prefer not answer vs. no (not estimable) | Superiority |
| Multivariable GEE modeling the probability of high PrEP adherence with predictor emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to visits with complete data (1518 of 1533 visits). This section provides p-values and odds ratio estimates for emotional violence. | GEE | 0.004 | Odds Ratio (OR) | 2.57 | 2-Sided | 95 | 1.35 | 4.92 | Estimates are for group emotional violence prefer not to answer vs. no. | Superiority |
| Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for the highest level of education. | Regression, Linear | 0.06 | Mean Difference (Final Values) | -0.11 | 2-Sided | 95 | -0.22 | 0.003 | Estimates are for highest level of education high school vs. college. | Superiority |
| Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence. | Regression, Linear | 0.76 | Mean Difference (Final Values) | -0.016 | 2-Sided | 95 | -0.12 | 0.09 | Superiority | Estimates are for group emotional violence yes vs. no. |
| Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence. | Regression, Linear | 0.09 | Mean Difference (Final Values) | 0.36 | 2-Sided | 95 | -0.06 | 0.78 | Superiority | Estimates are for group emotional violence prefer not to answer vs. no. |