An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,391
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
DTP, Continue DTP if Responsive
DTP:
- Standard of care (SoC), minus clinic referrals for antiretroviral therapy (ART) treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if virally suppressed at 6 months.
Intervention: DTP (Behavioral)
DTP, Standard of Care (SoC) if Responsive
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
SoC:
- HIV counseling and testing (HTC)
- Sexually transmitted infection (STI) screening and treatment
- Tuberculosis (TB) screening and referral
- Health education through peer educators and peer supported follow-up related to linkages to care
- Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
Intervention: DTP (Behavioral)
DTP, Continue DTP if Non-Responsive
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if not virally suppressed at 6 months.
Intervention: DTP (Behavioral)
DTP, DTP+ICM if Non-Responsive
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through female sex worker (FSW) initiated interaction
Receives both interventions at 6 months if non-virally suppressed.
Intervention: DTP (Behavioral)
DTP, DTP+ICM if Non-Responsive
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through female sex worker (FSW) initiated interaction
Receives both interventions at 6 months if non-virally suppressed.
Intervention: ICM (Behavioral)
ICM, Continue ICM if Responsive
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if virally suppressed.
Intervention: ICM (Behavioral)
ICM, SoC if Responsive
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
SoC:
- HIV counseling and testing (HTC)
- STI screening and treatment
- TB screening and referral
- Health education through peer educators and peer supported follow-up related to linkages to care
- Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
Intervention: ICM (Behavioral)
ICM, Continue ICM if Non-Responsive
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if non-virally suppressed.
Intervention: ICM (Behavioral)
ICM, ICM+DTP if Non-Responsive
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
Intervention: DTP (Behavioral)
ICM, ICM+DTP if Non-Responsive
ICM:
- Standard of Care
- Assignment of peer case manager
- Face-to-face meeting to tailor ICM approach to FSW preference
- Self-efficacy building in face-to-face sessions and bi-weekly text messages
- Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
DTP:
- Standard of care, minus clinic referrals for ART treatment initiation and management.
- Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
Intervention: ICM (Behavioral)
Standard of Care (SoC)
Standard of Care (SoC):
- HIV counseling and testing (HTC)
- Sexually transmitted infection (STI) screening and treatment
- Tuberculosis (TB) screening and referral
- Health education through peer educators and peer supported follow-up related to linkages to care
- Referrals to Department of Health (DoH) primary healthcare clinics or TB HIV Care (THC) drop-in center for ART treatment initiation and management
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participants' Costs South in African Rand (ZAR)(Baseline, Follow-up up to 5 months)
- Retention and Viral Suppression of Non-Responders(18 months after enrollment)
- Durability of Retention and Viral Suppression of Responders(Up to 18 months after enrollment)
- Loss-to-Follow-Up(18 months after study enrollment)
- Intervention Acceptability(Acceptability of each intervention at 6 month timepoint)
- Risk Factors of Loss to Follow-up(Up to 18 months after enrollment)
- Adherence Assessment(18 months)
- Viral Suppression of Retained(Up to 18 months after enrollment)
- 2nd/3rd Line ART(Up to 18 months after enrollment)
- ART Resistance(Up to 18 months after enrollment)