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

NCT03099707 | Completed Results

• 1 other identifier: 2016P002222
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Treatment; ART; South Africa

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• HIV-1 RNA Suppression at 6 Months Post-enrollment

  6 months

• CD4

  6 months

• Number of Participants With Intervention Acceptability

  Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks

• Number of Participants With Intervention Feasibility

  Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks

Other Outcomes (11)

• Time to Event Analysis of ART Initiation

  6 months

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

  baseline and 6 months

• Short-form 8 (SF-8)

  baseline and 6 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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).

Treatment Ambassador Intervention

ACTIVE COMPARATOR

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.

Behavioral: Treatment Ambassador

Interventions

Treatment Ambassador 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.

Treatment Ambassador Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent (e.g., due to intoxication or mental incapacity,
• Persons less than 18 years of age,
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Cape Town: collaborator

Study Sites (1)

Desmond Tutu HIV Foundation

Cape Town, South Africa

Location

Related Publications (1)

• 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.

  PMID: 33125587 RESULT

Results Point of Contact

• Title: Ingrid T. Katz
• Organization: Brigham and Women's Hospital

ikatz2@bwh.harvard.edu

617-525-8194

Study Officials

• Ingrid Katz

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Research Scientist

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 4, 2017
• Study Start: April 12, 2017
• Primary Completion: December 31, 2017
• Study Completion: October 31, 2018
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)