Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500172
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 29, 2019
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
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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
HIV-1 Virologic Response Behavioral: DTP Behavioral: ICM Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1143 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).
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 : June 22, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500172


Contacts
Layout table for location contacts
Contact: Carly A Comins, MPH 410-582-4274 ccomins1@jhu.edu
Contact: Stefan Baral, MD, MPH 410-502-8975 sbaral@jhu.edu

Locations
Layout table for location information
South Africa
TB HIV Care Recruiting
Durban, South Africa
Contact: Vijayanand Guddera, PhD    +27 82 448 7184    VGuddera@tbhivcare.org   
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
Layout table for investigator information
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)

Documents provided by Johns Hopkins Bloomberg School of Public Health:
Informed Consent Form  [PDF] April 2, 2018


Layout table for additonal information
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03500172    
Other Study ID Numbers: R01NR016650 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
HIV
Female Sex Workers
Viral Suppression
South Africa
Decentralized care
Antiretroviral therapy
Differentiated care