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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH114752 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Albert Einstein College of Medicine | OTHER |
| Rwanda Military Hospital | OTHER |
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The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).
Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early 1 | Experimental | Advance to spaced-out appointments at month 6 after a single viral load is measured. |
|
| Early 2 | Experimental | Advance to spaced-out appointments at month 6 after two viral loads are measured. |
|
| Usual Care | No Intervention | Do not advance to spaced-out appointments during study period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early spaced-out appointments | Other | Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Suppression | Percentage of participants with suppressed viral load (less than 200 copies/ml) | Measured at 12 months after enrollment into ART care |
| Measure | Description | Time Frame |
|---|---|---|
| Appointment Adherence | Proportion of participants that attended all pharmacy and clinical appointments | Measured at 12 months after enrollment into ART care |
| Participant Acceptability of Reduced Time to Spaced-out Appointments |
| Measure | Description | Time Frame |
|---|---|---|
| Enacted and Internalized Stigmas | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Ross | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rwanda Military Hospital | Kigali | Rwanda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38693537 | Derived | Ross J, Anastos K, Hill S, Remera E, Rwibasira GN, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Zhang C, Nash D, Yotebieng M, Murenzi G. Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial. BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z. | |
| 33895720 | Derived | Ross J, Murenzi G, Hill S, Remera E, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Habimana DS, Mugwaneza P, Zhang C, Yotebieng M, Anastos K. Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study. BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443. |
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As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early 1 | Advance to spaced-out appointments at month 6 after a single viral load is measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| FG001 | Early 2 | Advance to spaced-out appointments at month 6 after two viral loads are measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| FG002 | Usual Care | Do not advance to spaced-out appointments during study period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. Their data were not included in baseline analysis or any further analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early 1 | Advance to spaced-out appointments at month 6 after a single viral load is measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| 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 | Viral Suppression | Percentage of participants with suppressed viral load (less than 200 copies/ml) | Note: as the primary, intention to treat outcome, persons who did not complete the study were treated as being not virally suppressed. 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. Their data were not included in the analyses. | Posted | Count of Participants | Participants | Measured at 12 months after enrollment into ART care |
|
Adverse event data were collected on participants during their participation in the study (12 months)
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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 | Early 1 | Advance to spaced-out appointments at month 6 after a single viral load is measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Became pregnant during study | Pregnancy, puerperium and perinatal conditions | MEDDra | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Ross | Montefiore Medical Center | 718-920-7064 | joross@montefiore.org |
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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 | Dec 23, 2020 | Jul 21, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2020 | May 12, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.
| Measured at 12 months after enrollment into ART care |
| Provider Acceptability of Reduced Time to Spaced-out Appointments | Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant. | Measured at 12 months after enrollment into ART care |
| Measured at 6 months after enrollment in ART care |
| Participant Health-related Costs | Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center. | 12-months |
| ART Adherence | Repeated measures analysis of patient self-reported ART adherence | Measured at 12-months after enrollment in ART care |
| ART Adherence | Repeated measures analysis of patient self-reported ART adherence | Measured at 6 months after enrollment in ART care |
| Perceived Quality of Life | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. | Measured at 6 months after enrollment in ART care |
| Perceived Quality of Life | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. | Measured at 12 months after enrollment in ART care |
| Satisfaction With Care | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. | Measured at 6 months after enrollment in ART care |
| Anticipated Stigma | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score. | Measured at 6 months after enrollment in ART care |
| Anticipated Stigma | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score. | Measured at 12 months after enrollment in ART care |
| Enacted and Internalized Stigmas | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). | Measured at 12 months after enrollment in ART care |
| Withdrawal by investigative team (participants did not meet eligibility criteria) |
|
| BG001 | Early 2 | Advance to spaced-out appointments at month 6 after two viral loads are measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| BG002 | Usual Care | Do not advance to spaced-out appointments during study period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ART Adherence | Days of ART missed in last 30 days | Mean | Standard Deviation | Days of ART missed in last 30 days |
|
| Satisfaction with care | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. | Mean | Standard Deviation | units on a scale |
|
| Enacted and Internalized Stigma | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). | Mean | Standard Deviation | units on a scale |
|
| Quality of life | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. | Mean | Standard Deviation | units on a scale |
|
| Anticipated stigma | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Early 2 | Advance to spaced-out appointments at month 6 after two viral loads are measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. |
| OG002 | Usual Care | Do not advance to spaced-out appointments during study period |
|
|
| Secondary | Appointment Adherence | Proportion of participants that attended all pharmacy and clinical appointments | Appointment adherence was defined in the protocol as the proportion of participants in each arm who attended all scheduled clinical appointments and ART pick-ups during the study. We planned to ascertain appointment adherence through review of participants' medical files at the conclusion of the study. During medical file review, it became apparent that scheduled appointments (i.e. next planned) were inconsistently documented. We therefore were unable to accurately ascertain this outcome. | Posted | Measured at 12 months after enrollment into ART care |
|
|
| Secondary | Participant Acceptability of Reduced Time to Spaced-out Appointments | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale (Likert) | Measured at 12 months after enrollment into ART care |
|
|
|
| Secondary | Provider Acceptability of Reduced Time to Spaced-out Appointments | Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant. | Overriding of study assignment was only examined for participants in intervention arms (Early 1 and Early 2). 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. As such, data for one 'Early 1' group participant was not included in the analyses. | Posted | Count of Participants | Participants | Measured at 12 months after enrollment into ART care |
|
|
|
| Other Pre-specified | Enacted and Internalized Stigmas | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). | Posted | Mean | Standard Deviation | score on a scale | Measured at 6 months after enrollment in ART care |
|
|
|
| Other Pre-specified | Participant Health-related Costs | Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center. | Posted | Mean | Standard Deviation | Rwandan Francs (currency) | 12-months |
|
|
|
| Other Pre-specified | ART Adherence | Repeated measures analysis of patient self-reported ART adherence | Posted | Mean | Standard Deviation | Days of ART missed in last 30 days | Measured at 12-months after enrollment in ART care |
|
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| Other Pre-specified | ART Adherence | Repeated measures analysis of patient self-reported ART adherence | Posted | Mean | Standard Deviation | Days of ART missed in last 30 days | Measured at 6 months after enrollment in ART care |
|
|
|
| Other Pre-specified | Perceived Quality of Life | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. | Posted | Mean | Standard Deviation | score on a scale | Measured at 6 months after enrollment in ART care |
|
|
|
| Other Pre-specified | Perceived Quality of Life | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. | Posted | Mean | Standard Deviation | score on a scale | Measured at 12 months after enrollment in ART care |
|
|
|
| Other Pre-specified | Satisfaction With Care | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Measured at 6 months after enrollment in ART care |
|
|
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| Other Pre-specified | Anticipated Stigma | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score. | Posted | Mean | Standard Deviation | score on a scale | Measured at 6 months after enrollment in ART care |
|
|
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| Other Pre-specified | Anticipated Stigma | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score. | Posted | Mean | Standard Deviation | score on a scale | Measured at 12 months after enrollment in ART care |
|
|
|
| Other Pre-specified | Enacted and Internalized Stigmas | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). | Posted | Mean | Standard Deviation | score on a scale | Measured at 12 months after enrollment in ART care |
|
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|
| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | Early 2 | Advance to spaced-out appointments at month 6 after two viral loads are measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. | 0 | 31 | 0 | 31 | 1 | 31 |
| EG002 | Usual Care | Do not advance to spaced-out appointments during study period | 2 | 28 | 0 | 28 | 2 | 28 |
| Incarcerated during study | Social circumstances | MEDDra | Non-systematic Assessment |
|
| Developed tuberculosis during study | Infections and infestations | MEDDra | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Male |
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| Title | Measurements |
|---|---|
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