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History of Changes for Study: NCT03500172
Adaptive Randomized Evaluation of HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
Latest version (submitted November 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2018 None (earliest Version on record)
2 April 17, 2018 Study Status and Study Identification
3 June 25, 2018 Recruitment Status, Study Status and Contacts/Locations
4 April 26, 2019 Study Status
5 May 15, 2020 Recruitment Status, Study Status and Contacts/Locations
6 July 31, 2020 Study Status and Study Design
7 August 30, 2021 Study Status
8 January 14, 2022 Recruitment Status and Study Status
9 July 8, 2022 Study Status
10 November 18, 2022 Study Status, Document Section and Arms and Interventions
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Study NCT03500172
Submitted Date:  April 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: R01NR016650
Brief Title: Adaptive Randomized Evaluation of HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
Official Title: An Adaptive Randomized Evaluation of Nurse-Led HIV Treatment Retention Interventions for Women Living With HIV in Durban, South Africa
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Not yet recruiting
Study Start: May 7, 2018
Primary Completion: November 30, 2020 [Anticipated]
Study Completion: November 30, 2021 [Anticipated]
First Submitted: April 9, 2018
First Submitted that
Met QC Criteria:
April 9, 2018
First Posted: April 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 9, 2018
Last Update Posted: April 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Johns Hopkins Bloomberg School of Public Health
Responsible Party: Sponsor
Collaborators: University of the Western Cape
TB/HIV Care
University of Toronto
University of California, San Francisco
National Institute for Communicable Diseases, South Africa
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
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.

Open or close this module Conditions
Conditions: HIV-1 Virologic Response
Keywords: HIV
Female Sex Workers
Viral Suppression
South Africa
Decentralized care
Antiretroviral therapy
Differentiated care
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Sequential Assignment
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).
Number of Arms: 8
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1143 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Retention and Viral Suppression of DTP verse ICM
[ Time Frame: 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
[ 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
2. Risk factors of uncontrolled viremia and/or lost to follow-up
[ Time Frame: 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
[ 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)
4. Adherence Assessment
[ Time Frame: 6, 12 and 18 months ]

Self-reported adherence and refill pick-up data to assess adherence across arms
5. Viral Suppression of Retained
[ Time Frame: Up to 18 months after enrollment ]

Among those retained, comparison of viral suppression across arms
6. Loss-to-Follow-Up
[ Time Frame: 18 months after study enrollment ]

Loss-to-follow-up across arms
7. Intervention Acceptability
[ Time Frame: Up to 18 months after enrollment ]

Participant reported intervention acceptability
8. 2nd/3rd Line ART
[ Time Frame: Up to 18 months after enrollment ]

Numbers switching to 2nd/3rd Line ART across arms
9. ART Resistance
[ Time Frame: Up to 18 months after enrollment ]

Report and compare resistance across arms
10. Comparative cost-effectiveness of intervention
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: Up to 18 months after enrollment ]

Proportion of face-to-face case manager sessions attended
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based: Yes
Only cisgender women will be enrolled into the study.
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Carly A Comins, MPH
Telephone: 410-582-4274
Email: ccomins1@jhu.edu
Central Contact Backup: Stefan Baral, MD, MPH
Telephone: 410-502-8975
Email: sbaral@jhu.edu
Study Officials: Stefan Baral, MD, MPH
Principal Investigator
Johns Hopkins Bloomberg School of Public Health
Harry Hausler, MD, MPH
Principal Investigator
TB/HIV Care
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:
Open or close this module Document Section
Informed Consent Form
Document Date: April 2, 2018
Uploaded: 04/09/2018 10:57
File Name: ICF_000.pdf
Study Protocol and Statistical Analysis Plan
Document Date: April 2, 2018
Uploaded: 04/09/2018 15:16
File Name: Prot_SAP_001.pdf

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