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

NCT ID: NCT03099707

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2018-10-31

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.

Conditions

HIV

Keywords

Treatment; ART; South Africa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Treatment Ambassador

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Theresa Katz, M.D.

Assistant Professor and Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid Katz

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Desmond Tutu HIV Foundation

Cape Town, , South Africa

Countries

South Africa

References

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.

Reference Type: RESULT

PMID: 33125587 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P002222

Identifier Type: -

Identifier Source: org_study_id