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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI131060 | U.S. NIH Grant/Contract | View source | |
| UNCPMZ 41901 | Other Identifier | UNC |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. The study will take place in Lilongwe, Malawi.
If the anticipated gains for the prevention of mother-to-child HIV transmission (PMTCT) programs are to be realized, adherence to antiretroviral regimens will be critical. To date, however, there are few evidence-based approaches that are scalable and sustainable in busy, programmatic settings where HIV burden is high. The study seeks to implement the intervention, which includes patient-centered counseling and adherence supporter training, for both HIV-positive (for antiretroviral therapy, or ART) and HIV-negative (for pre-exposure prophylaxis, or PrEP) pregnant and breastfeeding women, thus providing a universal approach to support PMTCT programs holistically. The study will enroll pregnant women 18 years of age or older receiving antenatal care services at one of the designated study facilities. In Group 1, the study will enroll 100 HIV-positive women who started (or re-started, after a 6 months or longer treatment interruption) a first-line ART regimen within the past 30 days. In Group 2, the study will enroll 200 HIV-negative women willing to initiate and continue oral PrEP, in the form of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), and who report factors that place them at elevated risk for HIV acquisition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a: iNSC and Adherence supporter training | Experimental | HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART. |
|
| Group 1b: Standard of Care | No Intervention | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). | |
| Group 2a: iNSC and Adherence supporter training | Experimental | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. |
|
| Group 2b: Standard of Care | No Intervention | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNSC and Adherence supporter training | Behavioral | Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) | The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL. | 6 months following study enrollment |
| Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only) | The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations. | 6 months following study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session | Extent to which Integrated Next Step Counseling (iNSC) was delivered as intended for each counseling session, obtained by audits of recorded counseling sessions. Counseling sessions were assessed according 50 evaluable actions. Each of these could be scored 0 (not done), 1 (partially done), and 2 (done well). These were aggregated into an overall score for fidelity, with an overall score range of 0-100. Higher scores represented greater counselor adherence to the iNSC framework. |
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Eligibility criteria for enrollment in Group 1 (HIV-positive women):
Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria for enrollment in Group 2 (HIV-negative women):
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Chi, MD, MSc | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bwaila District Hospital | Lilongwe | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40293995 | Derived | Mutale W, Graybill LA, Saidi F, Phanga T, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson BD, Mollan KR, Chi BH. Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial. PLoS One. 2025 Apr 28;20(4):e0319735. doi: 10.1371/journal.pone.0319735. eCollection 2025. | |
| 37757844 | Derived | Chi BH, Saidi F, Graybill LA, Phanga T, Mollan KR, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson B, Kalua T, Phiri S, Mutale W. A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):42-51. doi: 10.1097/QAI.0000000000003309. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1a: Integrated Next Step Counseling (iNSC) and Adherence Supporter Training | HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising Integrated Next Step Counseling (iNSC) and adherence supporter training for antiretroviral therapy (ART). iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2019 |
This is a parallel pilot randomized trial in which participants randomly assigned to the control arm will receive antiretroviral adherence support about HIV treatment and prevention. Those randomized to the intervention arm will additionally receive a multi-component support strategy comprising integrated next-step counseling (iNSC) and adherence supporter training.
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| 6 months following study enrollment |
| Reported Level of Satisfaction by Participants for the Study Intervention | Satisfaction with overall intervention. Participants were asked: "How satisfied would you say you are with the program overall (both the iNSC and the Adherence Supporter)?" The five possible answers are shown below. | 6 months following study enrollment |
| Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only) | The secondary outcome measure is retention in care with HIV viral suppression, defined as <1000 copies/mL. | 6 months following study enrollment |
| Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only) | The secondary outcome measure is retention in care with self-reported ART adherence >95% over the last 30 days. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized. | 6 months following study enrollment |
| Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only) | The secondary outcome is retention in care with >95% adherence to PrEP over the last 30 days by participant self-report. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized. | 6 months following study enrollment |
| Number of Participants Reporting Social Harms | Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made. | 3 months following study enrollment |
| Number of Participants Reporting Social Harms | Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made. | 6 months following study enrollment |
| 34193491 | Derived | Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-046032. |
| FG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| FG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising Integrated Next Step Counseling (iNSC) and adherence supporter training for HIV pre-exposure prophylaxis (PrEP). iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| FG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
| Liveborn Infants During Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1a: iNSC and Adherence Supporter Training | HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| BG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| BG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| BG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||
| Gestational age at enrollment, continuous | Median | Inter-Quartile Range | weeks |
|
| 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 | Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) | The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL. | Pregnant women living with HIV (Groups 1a and 1b only) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Primary | Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only) | The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations. | Pregnant women who are HIV-negative (Groups 2a and 2b only) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Secondary | Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session | Extent to which Integrated Next Step Counseling (iNSC) was delivered as intended for each counseling session, obtained by audits of recorded counseling sessions. Counseling sessions were assessed according 50 evaluable actions. Each of these could be scored 0 (not done), 1 (partially done), and 2 (done well). These were aggregated into an overall score for fidelity, with an overall score range of 0-100. Higher scores represented greater counselor adherence to the iNSC framework. | Population comprises those in Groups 1a and 2a who attended their six month study visit and had a recorded counseling session for the visit | Posted | Median | Inter-Quartile Range | score on a scale | 6 months following study enrollment |
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| Secondary | Reported Level of Satisfaction by Participants for the Study Intervention | Satisfaction with overall intervention. Participants were asked: "How satisfied would you say you are with the program overall (both the iNSC and the Adherence Supporter)?" The five possible answers are shown below. | Satisfaction with the intervention measured only in those randomized to receive the intervention (Groups 1a and 2a) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Secondary | Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only) | The secondary outcome measure is retention in care with HIV viral suppression, defined as <1000 copies/mL. | Pregnant women living with HIV (Groups 1a and 1b only) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Secondary | Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only) | The secondary outcome measure is retention in care with self-reported ART adherence >95% over the last 30 days. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized. | Pregnant women living with HIV (Groups 1a and 1b only) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Secondary | Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only) | The secondary outcome is retention in care with >95% adherence to PrEP over the last 30 days by participant self-report. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized. | Pregnant women who are HIV-negative (Groups 2a and 2b only) | Posted | Count of Participants | Participants | 6 months following study enrollment |
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| Secondary | Number of Participants Reporting Social Harms | Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made. | Posted | Count of Participants | Participants | 3 months following study enrollment |
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| Secondary | Number of Participants Reporting Social Harms | Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made. | Posted | Count of Participants | Participants | 6 months following study enrollment |
|
From study enrollment through follow-up at 6 months (study visit window of 152 to 234 days).
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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 | Group 1a: iNSC and Adherence Supporter Training | HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. | 0 | 51 | 4 | 51 | 1 | 51 |
| EG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). | 0 | 49 | 2 | 49 | 7 | 49 |
| EG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. | 0 | 100 | 11 | 100 | 5 | 100 |
| EG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). | 0 | 100 | 6 | 100 | 6 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal demise (stillbirths and spontaneous abortions) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Incident HIV infection (maternal) | Infections and infestations | Systematic Assessment | This applies only to Groups 2a and 2b. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Preterm birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Chi | University of North Carolina at Chapel Hill | 9194454147 | bchi@med.unc.edu |
| Dec 12, 2022 |
| Prot_SAP_000.pdf |
| 20-24 years |
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| 25-29 years |
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| 30-34 years |
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| 35+ years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Did not complete primary school |
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| OG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
|
|
| OG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
|
|
| OG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
|
|
| OG001 |
| Group 1b: Standard of Care |
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
|
|
| OG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
|
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| OG001 | Group 1b: Standard of Care | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
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| OG001 |
| Group 1b: Standard of Care |
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
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| OG001 |
| Group 1b: Standard of Care |
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| OG002 | Group 2a: iNSC and Adherence Supporter Training | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. iNSC and Adherence supporter training: Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. |
| OG003 | Group 2b: Standard of Care | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
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