NCT03099707

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

Completed NA Results posted Last updated 6 December 2021

What this trial tests

NA trial testing Treatment Ambassador in HIV in 84 participants. Completed in 31 October 2018.

Timeline

12 April 2017

Primary endpoint
31 December 2017

31 October 2018

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	84
Start date	12 April 2017
Primary completion	31 December 2017
Estimated completion	31 October 2018
Sites	1 location across South Africa

Drugs / interventions tested

• Treatment Ambassador

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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 int

Group	Value	95% CI
Standard of Care	1
Treatment Ambassador Intervention	5

Number of Participants With Intervention Acceptability Secondary · Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks

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

Group	Value	95% CI
Treatment Ambassador Intervention	25

Number of Participants With Intervention Feasibility Secondary · Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks

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

Group	Value	95% CI
Standard of Care	0
Treatment Ambassador Intervention	37

Number of Participants Who Reported Having Fewer Drinks at 6 Months Than at Baseline Secondary · baseline and 6 months

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.

Group	Value	95% CI
Standard of Care	3
Treatment Ambassador Intervention	7

Short-form 8 (SF-8) Secondary · baseline and 6 months

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

Group	Value	95% CI
Standard of Care	0.0	± 1.0
Treatment Ambassador Intervention	-0.1	± 1.1

Change in Self-reported Coping/Ability to Cope Over Time Secondary · baseline and 6 months

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.

Group	Value	95% CI
Standard of Care	1.53	± 0.85
Treatment Ambassador Intervention	1.24	± 0.57

Change in Self-reported Belief in ARV Efficacy/Trust in Antiretrovirals Over Time Secondary · baseline and 6 months

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.

Group	Value	95% CI
Standard of Care	2.93	± 0.34
Treatment Ambassador Intervention	3.00	± 0.24

Medical Outcomes Study (MOS) Social Support Survey Secondary · baseline and 6 months

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 qu

Group	Value	95% CI
Standard of Care	4.22	± 0.64
Treatment Ambassador Intervention	4.39	± 0.65

Patient-Health Questionnaire (PHQ)-9 Secondary · baseline and 6 months

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

Group	Value	95% CI
Standard of Care	0.61	± 0.56
Treatment Ambassador Intervention	0.32	± 0.24

Change in Self-reported Internalized Stigma Over Time Secondary · baseline and 6 months

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 agr

Group	Value	95% CI
Standard of Care	2.61	± 1.50
Treatment Ambassador Intervention	2.30	± 1.26

Change in Self-reported Disclosure Concerns Over Time Secondary · baseline and 6 months

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 e

Group	Value	95% CI
Standard of Care	3.47	± 1.72
Treatment Ambassador Intervention	3.81	± 1.61

Change in Self-reported Barriers and Competing Needs Over Time Secondary · Baseline and 6 months

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

Group	Value	95% CI
Standard of Care	4.55	± 2.50
Treatment Ambassador Intervention	3.91	± 2.17

Sponsor's own description

This study will evaluate the feasibility and acceptability of the Treatment Ambassador program - a peer-supported intervention targeting individuals living with HIV who have not started on treatment within at least 3 months of testing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Treatment Ambassador Program: A Highly Acceptable and Feasible Community-Based Peer Intervention for South Africans Living with HIV Who Delay or Discontinue Antiretroviral Therapy.
   Katz IT, Bogart LM, Fitzmaurice GM, Staggs VS, et al · · 2021 · cited 18× · PMID 33125587 · DOI 10.1007/s10461-020-03063-1