Clinical trial NCT03099707: The Treatment Ambassador Program: A Pilot Intervention to Increase Treatment Initiation
Official title: The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Treatment
ART
South Africa
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2017-04-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Global HIV treatment initiatives have focused on increasing access to antiretroviral therapy (ART), with the goal of creating an "AIDS-free generation." There is growing evidence, however, that treatment availability alone is insufficient to stop the spread of the disease. Countries where HIV is hyperendemic, such as South Africa, will not achieve population-level reductions in HIV until incident infections have been dramatically reduced over a lifetime, and people living with HIV (PLWH) no longer wait to start treatment until they have symptoms of advanced AIDS. As South Africa expands ART eligibility to all people living with HIV, it remains unclear if promoting earlier ART initiation will lead to widespread uptake. These operational realities raise two fundamental questions: how will we close the gap from the 3.4 million PLWH currently on ART to treating the over seven million people who need care; and what does this portend for the future of Treatment as Prevention in South Africa? The investigators' prior research suggests that optimizing ART initiation for PLWH in South Africa will require an intervention to reduce individual barriers to starting ART, promote social support, and enhance linkages to the healthcare system. In the proposed study, the investigators will build upon our prior research to pilot test a socio-behavioral multi-component peer intervention, to ensure that South Africans living with HIV initiate and sustain treatment. Investigators will test this intervention through a pilot randomized-controlled trial. This multi-component intervention is designed to address barriers to ART initiation identified in prior qualitative research, framed through the Theory of Triadic Influence (TTI). TTI focuses upon three "streams of influence" that impact health behavior at the individual-, social-, and structural-levels. The intervention will be delivered by "Treatment Ambassadors," who are PLWH who will function in multiple capacities, and have received intensive training in motivational interviewing (MI), peer-support, and peer navigation. They will then provide the intervention in eight sessions over 8-14 weeks. The intervention will be individually tailored to address the three streams of influence on patient decision-making as follows: MI will address individual perceived risk and ambivalence in decision-making; peer-support will target interpersonal social factors; and patient navigation will promote ART initiation and counter structural barriers.

Investigators will enroll 90 participants (45 in each arm) with the goal of assessing feasibility and acceptability. Investigators enrolled 84 participants in total. The 90 participant mark was not met due to time constraints and our eligibility requirements. In addition, preliminary efficacy will be assessed through the following measures:

Primary Outcome Measure: Timely ART initiation (initiation within 3 months of enrollment) (assessed through the National Health Laboratory Service, pharmacy records, and medical chart abstraction).

Secondary Outcomes Measures: 1) HIV-1 RNA Suppression within the first 6 months of study enrollment (assessed through the National Health Laboratory Service).

2) Behavioral Factors associated with failure to initiate ART in a timely manner.

Eligibility criteria: Inclusion Criteria:

1. Adults living with HIV who are 18 years and older, who have not initiated ART within 3 months of learning their status
2. ART naïve,
3. Live within 60 km the testing center (due to prohibitive costs of following participants to remote locations);
4. English or Xhosa speaking; and
5. Eligible for treatment under current South Africa guidelines

Exclusion Criteria:

1. Unable to provide informed consent (e.g., due to intoxication or mental incapacity,
2. Persons less than 18 years of age,
3. Women who report current pregnancy at the time of consent. We are choosing to not include pregnant women in this study, because the study's recruitment site refers pregnant clients to more specialized care facilities that may better suit their needs.

Primary outcomes:
measure: Number of Participants With Treatment Initiation at 3 Months After Study Enrollment
timeFrame: 3 months
Secondary outcomes:
measure: HIV-1 RNA Suppression at 6 Months Post-enrollment
timeFrame: 6 months
measure: CD4
timeFrame: 6 months
measure: Number of Participants With Intervention Acceptability
timeFrame: Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks
measure: Number of Participants With Intervention Feasibility
timeFrame: Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks
Other outcomes:
measure: Time to Event Analysis of ART Initiation
timeFrame: 6 months
measure: Number of Participants Who Reported Having Fewer Drinks at 6 Months Than at Baseline
timeFrame: baseline and 6 months
measure: Short-form 8 (SF-8)
timeFrame: baseline and 6 months
measure: Change in Self-reported Coping/Ability to Cope Over Time
timeFrame: baseline and 6 months
measure: Change in Self-reported Belief in ARV Efficacy/Trust in Antiretrovirals Over Time
timeFrame: baseline and 6 months
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: baseline and 6 months
measure: Patient-Health Questionnaire (PHQ)-9
timeFrame: baseline and 6 months
measure: Change in Self-reported Internalized Stigma Over Time
timeFrame: baseline and 6 months
measure: Change in Self-reported Disclosure Concerns Over Time
timeFrame: baseline and 6 months
measure: Change in Self-reported Anticipated Stigma Over Time
timeFrame: baseline and 6 months
measure: Change in Self-reported Barriers and Competing Needs Over Time
timeFrame: Baseline and 6 months
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
Study officials:
affiliation: Brigham and Women's Hospital
name: Ingrid Katz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz IT, Bogart LM, Fitzmaurice GM, Staggs VS, Gwadz MV, Bassett IV, Cross A, Courtney I, Tsolekile L, Panda R, Steck S, Bangsberg DR, Orrell C, Goggin K. 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. AIDS Behav. 2021 Apr;25(4):1129-1143. doi: 10.1007/s10461-020-03063-1. Epub 2020 Oct 30.