HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT03500172
Collaborator
University of the Western Cape (Other), TB/HIV Care (Other), University of Toronto (Other), University of California, San Francisco (Other), National Institute for Communicable Diseases, South Africa (Other)
1,391
1
8
42.5
32.7

Study Details

Study Description

Brief Summary

The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment <50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DTP
  • Behavioral: ICM
N/A

Detailed Description

RATIONALE: Approximately 60% of the estimated 121,000 - 167,000 female sex workers (FSW) in South Africa are living with HIV. Research suggests only 39% of these women are currently on antiretroviral therapy (ART) and face individual, network and structural level barriers to ART initiation, retention and adherence. To prevent clinical treatment outcome disparities and reduce onward HIV transmission, understanding how best to adapt and implement, scalable and effective interventions to promote viral suppression among marginalized women is paramount. The overall goal of the Siyaphambili study is to inform South African HIV service delivery and scale up determining the most cost-effective package needed to achieve viral suppression among FSW and by characterizing the FSW most in need of these intensive HIV treatment interventions.

HYPOTHESIS: DTP and ICM will be equally effective at achieving viral suppression and will have a synergistic effect when combined and targeted at those who remain non-responsive to either isolated intervention. Additionally, an adaptive, graduated multicomponent intervention to achieve viral suppression would be preferred under standard thresholds for cost-effectiveness over single-intensity interventions or intensive multicomponent interventions for all FSW.

INTERVENTION: The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among FSW living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.

STUDY DESIGN: A sequential multistage adaptive randomized study, embedded within the TB/HIV Care program in Durban, South Africa, will enroll 800 viremic FSW into the 18-month trial. Women will be randomized to either DTP or ICM at enrolment and rerandomized 6 months after enrolment based on their response to the initial intervention.

PRIMARY OBJECTIVE: To compare the effectiveness and durability of nurse-led DTP and ICM in isolation or in combination to achieve viral suppression.

SECONDARY OBJECTIVE: To estimate the incremental impact and cost-effectiveness associated with study interventions and combination of interventions.

OUTCOMES: The primary outcome of the study is retention and viral suppression among those initially randomized to the DTP verse ICM intervention. The secondary outcomes are retention and viral suppression of non-responders, retention and viral suppression among month 6 non-responders, retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention verse combined DTP+ICM, risk stratification tool, durability of retention and viral suppression of responders, to assess adherence, to assess viral suppression of retained, loss-to-follow-up, intervention acceptability, switching to 2nd/3rd line ART, and ART resistance.

ANALYTIC PLAN:
Primary analysis for primary outcome:

Retention in ART care and viral suppression will be a combined outcome in an intention to treat (ITT) analysis at 18 months to compare participants initially randomized to the DTP verse ICM intervention. Viral suppression is defined as a viral load assessment <50 RNA copies/mL and participants lost to follow up or who experience death during the trial duration will be grouped with non-virally suppressed participants.

Study Design

Study Type:
Interventional
Actual Enrollment :
1391 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
This sequential multistage adaptive randomized trial (SMART) assesses two interventions to address treatment barriers: (1) nurse-led mobile decentralized treatment programs (DTP) and (2) peer-led, individualized case management (ICM).This sequential multistage adaptive randomized trial (SMART) assesses two interventions to address treatment barriers: (1) nurse-led mobile decentralized treatment programs (DTP) and (2) peer-led, individualized case management (ICM).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
Actual Study Start Date :
Jun 22, 2018
Actual Primary Completion Date :
Nov 24, 2021
Actual Study Completion Date :
Jan 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DTP, Continue DTP if Responsive

Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

Active Comparator: DTP, Standard of Care (SoC) if Responsive

Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

Active Comparator: DTP, Continue DTP if Non-Responsive

Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

Active Comparator: DTP, DTP+ICM if Non-Responsive

Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Active Comparator: ICM, Continue ICM if Responsive

Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Active Comparator: ICM, SoC if Responsive

Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Active Comparator: ICM, Continue ICM if Non-Responsive

Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Active Comparator: ICM, ICM+DTP if Non-Responsive

Behavioral: DTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.

Behavioral: ICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.

Outcome Measures

Primary Outcome Measures

  1. Retention and Viral Suppression of DTP verse ICM [18 months after enrollment]

    Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM

Secondary Outcome Measures

  1. Retention and Viral Suppression of Non-Responders [18 months after enrollment]

    Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM

  2. Risk factors of uncontrolled viremia and/or lost to follow-up [Up to 18 months after enrollment]

    Risk stratification tool to identify FSW at highest risk for uncontrolled viremia and/or lost to follow-up.

  3. Durability of Retention and Viral Suppression of Responders [Up to 18 months after enrollment]

    Durability of retention and viral suppression among 6 month responders continuing on DTP or ICM vs. those randomized to revert to standard of care (SoC)

  4. Adherence Assessment [6, 12 and 18 months]

    Self-reported adherence and refill pick-up data to assess adherence across arms

  5. Viral Suppression of Retained [Up to 18 months after enrollment]

    Among those retained, comparison of viral suppression across arms

  6. Loss-to-Follow-Up [18 months after study enrollment]

    Loss-to-follow-up across arms

  7. Intervention Acceptability [Up to 18 months after enrollment]

    Participant reported intervention acceptability

  8. 2nd/3rd Line ART [Up to 18 months after enrollment]

    Numbers switching to 2nd/3rd Line ART across arms

  9. ART Resistance [Up to 18 months after enrollment]

    Report and compare resistance across arms

  10. Comparative cost-effectiveness of intervention [Up to 18 months after enrollment]

    Comparison of intervention cost-effectiveness according to order of intervention and duration of intervention received

Other Outcome Measures

  1. DTP Pick-Ups [Up to 18 months after enrollment]

    Number and proportion of DTP pick-ups attended within 7-days of scheduled visit

  2. ICM Phone-Based Contacts [Up to 18 months after enrollment]

    Number of ICM phone-based contacts; proportion of participant initiating phone-based contacts at 6, 12 and 18 months

  3. ICM In-Person Meetings [Up to 18 months after enrollment]

    Proportion of face-to-face case manager sessions attended

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Sells sex for goods or money as their main source of income

  2. Assigned female sex at birth

  3. ≥ 18 years of age

  4. Living with HIV; diagnosed ≥ 6 months prior

  5. Currently living in Durban

  6. If on ART, initiated ≥2 months prior

Exclusion Criteria:
  1. Engagement in an ongoing HIV treatment research study

  2. Planning on leaving Durban for more than 3 months in the following 12 months

  3. Pregnant at time of enrollment

  4. On a second line or third ART regimen

  5. Participating in an adherence club

Contacts and Locations

Locations

Site City State Country Postal Code
1 TB HIV Care Durban South Africa

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • University of the Western Cape
  • TB/HIV Care
  • University of Toronto
  • University of California, San Francisco
  • National Institute for Communicable Diseases, South Africa

Investigators

  • Principal Investigator: Stefan Baral, MD, MPH, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Harry Hausler, MD, MPH, TB/HIV Care

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT03500172
Other Study ID Numbers:
  • R01NR016650
First Posted:
Apr 17, 2018
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins Bloomberg School of Public Health

Study Results

No Results Posted as of Jul 12, 2022