The Treatment Ambassador Program: A Pilot Intervention to Increase Treatment Initiation

介入なし：Standard of Care

Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only. This group will not receive any additional engagement to care intervention. Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).

アクティブコンパレータ：Treatment Ambassador Intervention

Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys). For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation. The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.

行動：Treatment Ambassador

This multi-component intervention, titled the "Treatment Ambassador Program," will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support.

Number of Participants With Treatment Initiation at 3 Months After Study Enrollment

Treatment Initiation will be measured at 3 months through clinic records, pharmacy data, and the National Health Laboratory Service (NHLS), a national database in South Africa. Primary data analysis will be an intent-to-treat analysis, which includes all randomized participants. Of note, every attempt will be made to continue assessing participants even if they drop out of treatment. In addition, investigators will replicate all analyses with the completers only. The hypothesis that the intervention will yield higher rates of antiretroviral therapy (ART) initiation by the completion of the intervention will be tested using Fisher's exact test; the treatment effect estimate will be summarized in terms of a relative risk and 95% confidence interval. Any baseline demographic or clinical variables identified as necessary covariates in preliminary analyses will be included in a logistic regression analysis that examines the main effect of treatment condition on the rates of ART initiation.

HIV-1 RNA Suppression at 6 Months Post-enrollment

HIV-1 RNA will be measured at 6 months year post enrollment among participants who start ART to allow for sub-group analyses of people living with HIV who start ART in the intervention vs. control groups. This will be accessible through NHLS and clinic data.

CD4

Mean CD4 counts at the 6 month assessment

Number of Participants With Intervention Acceptability

Satisfaction with intervention content, delivery, length using a client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options

Number of Participants With Intervention Feasibility

Intervention feasibility measured by attendance, retention for outcome assessments, fidelity

Time to Event Analysis of ART Initiation

Investigators will perform a Time to Event Analysis of Treatment Initiation and compare this between control and intervention arms.

Data not available - only measured at 3 months to capture the importance of early treatment initiation

Number of Participants Who Reported Having Fewer Drinks at 6 Months Than at Baseline

Assessed through self-reported measures of alcohol use: percent reporting fewer daily drinks at six months than at baseline.

Participants were asked "How often do you have a drink containing alcohol (like beer, wine, or liquor)?" (Never, less than monthly, monthly....4 or more times a week). If they gave an answer other than "Never," they were then asked "How many drinks of any kind containing alcohol do you have on a typical day when you are drinking?" (1 or 2; 3 or 4...10 or more).

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Short-form 8 (SF-8)

Change in self-reported General Health over time. We compared the difference in scores between baseline and six months.

The SF-8 is an eight question survey for measuring general physical and mental health. It is a shortened version of the SF-36 and the results are interpreted using the same methods. First, items are recorded on a 0 (lowest score) to 100 (highest score) scale, per a scoring key developed by RAND. Then, items in the same scale are averaged together so that each scale representing different elements of health has its own score. Scores represent the average for all questions the participant answered (the percentage of total possible score achieved). The higher the score, the better the participant's health.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Change in Self-reported Coping/Ability to Cope Over Time

Brief COPE. We compared the difference in scores between baseline and six months.

The Brief COPE was developed by Carver, C. S. and provides a condensed version of the full COPE tool which can be modified by choosing only select scales. We used a 2-item scale (both related to alcohol and drug use, min=1, max=4) based on factor analysis results. Higher scores are worse (more use of alcohol/drugs to feel better/get through). We averaged the 2 items to calculate the scale score.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Change in Self-reported Belief in ARV Efficacy/Trust in Antiretrovirals Over Time

Perceptions of ARV Therapy Scale, HCSUS. We compared the difference in scores between baseline and six months.

ARV efficacy was measured using an 8-item scale. For each item, min=1, max=4. Higher scores are better (higher belief in ARV efficacy).

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Medical Outcomes Study (MOS) Social Support Survey

Change in self-reported perceived social support over time. We compared the difference in scores between baseline and six months.

The Social Support Survey contains four subscales (emotional/informational, tangible, affectionate, and positive social interaction) and an overall social support index. A higher score for any of the subscales or the index indicates higher levels of social support. Each subscale score is calculated by finding the average of all the scores in that subscale. The index is found by calculating the average of all the items. Social support was measured by asking eight questions each with a scale of one to five (five being the most support). The minimum score was 8 (least social support) and the maximum was 40 (most social support).

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Patient-Health Questionnaire (PHQ)-9

Change in self-reported depression over time. We compared the difference in scores between baseline and six months.

Depression and anxiety symptoms and somatic complaints were measured using the 9-item Patient Health Questionnaire (PHQ), which scores DSM-IV criteria from 0 (not at all) to 3 (nearly every day). The subtotals are summed to create the total score. 0-4 is interpreted as minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 as moderately severe depression, and 20-27 as severe depression.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Change in Self-reported Internalized Stigma Over Time

Internalized Stigma measure developed by Kalichman et al. We compared scores at baseline and six months.

Internalized stigma was measured using the Internalized AIDS-Related Stigma Scale. This six-item scale is used to measure internalized stigma. Participants either agree (which scores them a "1") or disagree (which scores them a "0") to each item and the total scale score is computed as the sum of the items with a minimum score of 0 and maximum score of 6. The higher the score, the higher their internalized stigma.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Change in Self-reported Disclosure Concerns Over Time

Disclosure concerns measure using Berger's HIV Stigma Scale. We modified the instrument to include eight statements related to disclosure concerns (i.e. I regret having told some people that I have HIV; I want to keep my HIV a secret) and participants responded disagree or agree. Disclosure concerns were measured by asking a set of eight questions, with a minimum score of 8 and a maximum score of 16. The higher the score, the greater the level of concern. We compared scores at baseline and six months.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.

Change in Self-reported Anticipated Stigma Over Time

Anticipated Stigma measure developed by Earnshaw et al. We used the HIV Stigma Framework to measure anticipated HIV stigma. This instrument consists of items relating to anticipated stigma from friends, family, and healthcare workers. Items were scored on 5-point Likert-type scales (1=very unlikely, 5=very likely). Higher scores indicate greater anticipated stigma.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. In this case, only one participant had not disclosed, but they were determined ineligible for the study.

Change in Self-reported Barriers and Competing Needs Over Time

Barriers and Competing Needs measure developed by Craw JA et al. We compared results at baseline and six months.

Barriers and competing needs were assessed by asking participants whether they had experienced each of 13 problems when medical care was needed in the past six months (e.g. not knowing where to find care, affordability of medications or transportation). The count of each participant's "yes" responses to these 13 yes/no items was taken as their score. Higher score means more barriers/competing needs.

Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey.