- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03500172
HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Durban, South Africa
- TB HIV Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sells sex for goods or money as their main source of income
- Assigned female sex at birth
- ≥ 18 years of age
- Living with HIV; diagnosed ≥ 6 months prior
- Currently living in Durban
- If on ART, initiated ≥2 months prior
Exclusion Criteria:
- Engagement in an ongoing HIV treatment research study
- Planning on leaving Durban for more than 3 months in the following 12 months
- Pregnant at time of enrollment
- On a second line or third ART regimen
- Participating in an adherence club
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: DTP, Continue DTP if Responsive
DTP:
Continues with DTP intervention if virally suppressed at 6 months. |
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
DTP:
SoC:
Returns to SoC if virally suppressed at 6 months. |
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
DTP:
Continues with DTP intervention if not virally suppressed at 6 months. |
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
DTP:
ICM:
Receives both interventions at 6 months if non-virally suppressed. |
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Active Comparator: ICM, Continue ICM if Responsive
ICM:
Continues with ICM intervention at 6 months if virally suppressed. |
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Active Comparator: ICM, SoC if Responsive
ICM:
SoC:
Returns to SoC if virally suppressed at 6 months. |
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Active Comparator: ICM, Continue ICM if Non-Responsive
ICM:
Continues with ICM intervention at 6 months if non-virally suppressed. |
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Active Comparator: ICM, ICM+DTP if Non-Responsive
ICM:
DTP:
Receives both interventions at 6 months if non-virally suppressed. |
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
No Intervention: Standard of Care (SoC)
Standard of Care (SoC):
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms
Time Frame: 18 months after enrollment
|
Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM.
Participants are considered to be retained in care if they attended their 18-month final study visit and were engaged in care at 18-months.
Viral suppression is defined as having less than 50 viral copies per milliliter.
|
18 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention and Viral Suppression of Non-Responders
Time Frame: 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
|
18 months after enrollment
|
Durability of Retention and Viral Suppression of Responders
Time Frame: 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)
|
Up to 18 months after enrollment
|
Viral Suppression of Retained
Time Frame: Up to 18 months after enrollment
|
Among those retained, comparison of viral suppression across arms
|
Up to 18 months after enrollment
|
ART Resistance
Time Frame: Up to 18 months after enrollment
|
Report and compare resistance across arms
|
Up to 18 months after enrollment
|
Risk Factors of Loss to Follow-up
Time Frame: Up to 18 months after enrollment
|
Risk stratification to identify FSW at highest risk for loss to follow-up.
|
Up to 18 months after enrollment
|
Adherence Assessment
Time Frame: 18 months
|
Self-reported adherence to assess adherence across arms
|
18 months
|
Loss-to-Follow-Up
Time Frame: 18 months after study enrollment
|
Loss-to-follow-up across arms (DTP vs. ICM).
This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM).
All 777 participants randomized at baseline are included here.
Loss to follow-up is defined as having missed the 18-month final study visit.
|
18 months after study enrollment
|
Intervention Acceptability
Time Frame: Acceptability of each intervention at 6 month timepoint
|
Participant reported intervention acceptability
|
Acceptability of each intervention at 6 month timepoint
|
2nd/3rd Line ART
Time Frame: Up to 18 months after enrollment
|
Number of participants who were tested and identified as resistant to first line therapy and were referred to a Department of Health facility for second line therapy across arms
|
Up to 18 months after enrollment
|
Comparative Cost-effectiveness of Intervention
Time Frame: Up to 18 months after enrollment
|
This outcome will be estimated using a modeling approach leveraging both the trial data and external evidence synthesis as model inputs.
Passive data collection is ongoing and cost-effectiveness results will be reported once available (by March 2024).
|
Up to 18 months after enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decentralized Treatment Provision (DTP) Pick-Ups
Time Frame: Up to 18 months after enrollment
|
Number and percentage of DTP pick-ups attended among participants randomized to received DTP.
|
Up to 18 months after enrollment
|
ICM Phone-Based Contacts
Time Frame: Up to 18 months after enrollment
|
Number of ICM phone-based contacts
|
Up to 18 months after enrollment
|
ICM In-Person Meetings
Time Frame: Up to 18 months after enrollment
|
Percentage of face-to-face case manager sessions attended
|
Up to 18 months after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stefan Baral, MD, MPH, Johns Hopkins Bloomberg School of Public Health
- Principal Investigator: Harry Hausler, MD, MPH, TB/HIV Care
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01NR016650 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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