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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099707
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Ingrid Theresa Katz, M.D., Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE April 12, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Treatment Initiation at 3 months after Study Enrollment [ Time Frame: 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 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • HIV-1 RNA Suppression at 6 months post-enrollment [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Mean CD4 counts at the 6 month assessment
  • Intervention acceptability [ Time Frame: 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
  • Intervention feasibility [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • HIV-1 RNA Suppression at 1 year post-enrollment [ Time Frame: 12 months ]
    HIV-1 RNA will be measured at 1 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 [ Time Frame: 12 months ]
    Mean CD4 counts at the 12 month assessment
  • Intervention acceptability [ Time Frame: 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
  • Intervention feasibility [ Time Frame: 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
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2018)
  • Time to Event Analysis of ART initiation [ Time Frame: 6 months ]
    Investigators will perform a Time to Event Analysis of Treatment Initiation and compare this between control and intervention arms.
  • Change in self-reported alcohol and recreational drug use over time [ Time Frame: baseline, 3 months, and 6 months ]
    Assessed through self-reported measures of alcohol and substance use
  • Change in self-reported General Health over time [ Time Frame: baseline, 3 months, and 6 months ]
    Short-form 8 (SF-8)
  • Change in self-reported Coping/Ability to cope over time [ Time Frame: baseline, 3 months, and 6 months ]
    Brief COPE
  • Change in self-reported belief in ARV Efficacy/Trust in antiretrovirals over time [ Time Frame: baseline, 3 months, and 6 months ]
    Perceptions of ARV Therapy Scale, HCSUS
  • Change in self-reported perceived social support over time [ Time Frame: baseline, 3 months, and 6 months ]
    Medical Outcomes Study (MOS) Social Support Survey
  • Change in self-reported depression over time [ Time Frame: baseline, 3 months, and 6 months ]
    Patient-Health Questionnaire (PHQ)-9
  • Change in self-reported internalized stigma over time [ Time Frame: baseline, 3 months, and 6 months ]
    Internalized Stigma measure developed by Kalichman et al.
  • Change in self-reported disclosure concerns over time [ Time Frame: baseline, 3 months, and 6 months ]
    Disclosure concerns measure developed by Kaai S. et al.
  • Change in self-reported anticipated stigma over time [ Time Frame: baseline, 3 months, and 6 months ]
    Anticipated Stigma measure developed by Earnshaw et al.
  • Change in self-reported barriers and competing needs over time [ Time Frame: baseline, 3 months, and 6 months ]
    Barriers and Competing Needs measure developed by Craw JA et al.
Original Other Pre-specified Outcome Measures
 (submitted: April 3, 2017)
  • Time to Event Analysis of ART initiation [ Time Frame: 6 months ]
    Investigators will perform a Time to Event Analysis of Treatment Initiation and compare this between control and intervention arms.
  • Change in self-reported alcohol and recreational drug use over time [ Time Frame: baseline, 3 months, and 12 months ]
    Assessed through self-reported measures of alcohol and substance use
  • Change in self-reported General Health over time [ Time Frame: baseline, 3 months, and 12 months ]
    Short-form 8 (SF-8)
  • Change in self-reported Coping/Ability to cope over time [ Time Frame: baseline, 3 months, and 12 months ]
    Brief COPE
  • Change in self-reported belief in ARV Efficacy/Trust in antiretrovirals over time [ Time Frame: baseline, 3 months, and 12 months ]
    Perceptions of ARV Therapy Scale, HCSUS
  • Change in self-reported perceived social support over time [ Time Frame: baseline, 3 months, and 12 months ]
    Medical Outcomes Study (MOS) Social Support Survey
  • Change in self-reported depression over time [ Time Frame: baseline, 3 months, and 12 months ]
    Patient-Health Questionnaire (PHQ)-9
  • Change in self-reported internalized stigma over time [ Time Frame: baseline, 3 months, and 12 months ]
    Internalized Stigma measure developed by Kalichman et al.
  • Change in self-reported disclosure concerns over time [ Time Frame: baseline, 3 months, and 12 months ]
    Disclosure concerns measure developed by Kaai S. et al.
  • Change in self-reported anticipated stigma over time [ Time Frame: baseline, 3 months, and 12 months ]
    Anticipated Stigma measure developed by Earnshaw et al.
  • Change in self-reported barriers and competing needs over time [ Time Frame: baseline, 3 months, and 12 months ]
    Barriers and Competing Needs measure developed by Craw JA et al.
 
Descriptive Information
Brief Title  ICMJE The Treatment Ambassador Program: A Pilot Intervention to Increase Treatment Initiation
Official Title  ICMJE The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans
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 86 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE HIV
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • No Intervention: 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).
  • Active Comparator: 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.
    Intervention: Behavioral: Treatment Ambassador
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
86
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2017)
90
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099707
Other Study ID Numbers  ICMJE 2016P002222
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ingrid Theresa Katz, M.D., Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE University of Cape Town
Investigators  ICMJE
Principal Investigator: Ingrid Katz Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP