HIVNCT03099707
The Treatment Ambassador Program: A Pilot Intervention to Increase Treatment Initiation
A study testing Treatment Ambassador in people with HIV, run by Brigham and Women's Hospital at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Treatment Ambassador
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Apr 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans
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.
Read the 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).
- Behavioral Factors associated with failure to initiate ART in a timely manner.
- Conditions
- HIV
- Being tested
- Treatment Ambassador
- Keywords
- Treatment, ART, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment AmbassadorBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treatment Ambassador |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
HIV-1 RNA Suppression at 6 Months Post-enrollment
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.
Measured: 6 months
CD4
Mean CD4 counts at the 6 month assessment
Measured: 6 months
Number of Participants With Intervention Acceptability
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
Measured: Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks
Number of Participants With Intervention Feasibility
Intervention feasibility measured by attendance, retention for outcome assessments, fidelity
Measured: Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start12 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Ingrid Theresa Katz, M.D., Brigham and Women's Hospital
- Investigators
- Ingrid Katz, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099707
- Sponsor's protocol ID
- 2016P002222
- Status last verified
- Oct 2021
- First submitted
- 17 Mar 2017
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33125587
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans
- ClinicalTrials.gov ID
- NCT03099707
- Acronym / sponsor ID
- 2016P002222
- Conditions
- HIV
- Keywords
- Treatment, ART, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- Behavioral Factors associated with failure to initiate ART in a timely manner.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Treatment AmbassadorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AmbassadorThis 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. | Behavioural | Treatment Ambassador Intervention |
Primary outcome
Number of Participants With 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.
4 secondary outcomes
HIV-1 RNA Suppression at 6 Months Post-enrollment
Time frame: 6 months
CD4
Time frame: 6 months
Number of Participants With Intervention Acceptability
Time frame: Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks
Number of Participants With Intervention Feasibility
Time frame: Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33125587Katz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Katz principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Ambassador in people with HIV, run by Brigham and Women's Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Initiation at 3 Months After Study Enrollment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.