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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: HIV-1 Virologic Response

Treatments: Behavioral: DTP; Behavioral: ICM

Study type: Interventional

Funder types: Other

Identifiers

NCT03500172

R01NR016650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,391 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

1,391 participants in 9 patient groups

DTP, Continue DTP if Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: DTP

DTP, Standard of Care (SoC) if Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: DTP

DTP, Continue DTP if Non-Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: DTP

DTP, DTP+ICM if Non-Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: ICM

Behavioral: DTP

ICM, Continue ICM if Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: ICM

ICM, SoC if Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: ICM

ICM, Continue ICM if Non-Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: ICM

ICM, ICM+DTP if Non-Responsive

Active Comparator group

Description:

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.

Treatment:

Behavioral: ICM

Behavioral: DTP

Standard of Care (SoC)

No Intervention group

Description:

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