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The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms

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ClinicalTrials.gov Identifier: NCT03977181
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Desmond Tutu HIV Centre
University of Washington
Information provided by (Responsible Party):
Foundation for Professional Development (Pty) Ltd

Brief Summary:
The investigators aim to 1) speed up access to and delivery of PrEP to young women, and 2) compare interventions to support and maximize the prevention-effective use of PrEP. Specifically, the investigators aim to answer the following two questions: 1) how can the study use existing community-based platforms to identify and deliver PrEP to those in need? and 2) which adherence support interventions are most likely to engender effective use of PrEP? The investigators propose to answer these questions by leveraging existing community-based HIV testing platforms in South Africa and use a mixed methods approach to optimize the PrEP cascade and evaluate a community-based PrEP adherence program for young women.

Condition or disease Intervention/treatment Phase
PrEP HIV Prevention Adolescence Cost-effectiveness Behavioral: Group-based Community Health Club Behavioral: Individual-based Adherence Support Not Applicable

Detailed Description:

Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in Southern and East Africa. In South Africa, the HIV incidence rate among young women ages 15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old young women. Given this high incidence of HIV, implementing effective HIV prevention strategies - including PrEP - is crucial to controlling HIV globally.

The proposed study leverages existing community-based HIV counseling and testing platforms in South Africa and evaluates, using a mixed methods approach, a community-based PrEP adherence program for young women whilst optimizing the PrEP cascade. Numerous barriers have been described that delay or block young women from accessing clinic-based health services, especially reproductive health and HIV testing and prevention services. Consequently, reaching young women at large scale with HIV prevention services requires delivery platforms outside of clinic-based facilities. Community-based counseling and testing programs have shown the greatest coverage and potential to achieve high levels of knowledge of HIV serostatus and linkage to HIV care. Using community-based counseling and testing programs, this proposal will deliver PrEP as part of a population-level combination prevention program, which is necessary to substantially reduce HIV incidence.

The investigators propose to answer key research questions through the following; Specific Aims: 1) Assess young women's uptake of PrEP when delivered through large-scale community-based HIV counseling and testing platforms in urban and rural settings in South Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective adherence to PrEP among young women, and 3) Evaluate the cost per young woman initiated on PrEP and provided adherence support through community-based platforms, and the cost-effectiveness per incident HIV infection averted. In order to achieve Aim 1, the study will leverage from on-going, at-scale CBCT programs and platforms (mobile unit and systematic home-based testing) to identify and link young women to community-based PrEP initiation services. In order to achieve Aim 2, the study will perform a 3-arm randomized controlled trial, with participants randomized to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; Arm 3) community-based medication dispensary.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigators will perform a 3-arm randomized controlled trial, with participants randomized to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; or Arm 3) community-based medication dispensary.
Masking: None (Open Label)
Masking Description: The allocation of study arm is concealed to study staff during randomization
Primary Purpose: Prevention
Official Title: Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Health Club
A group-based community health club akin to an ART adherence club
Behavioral: Group-based Community Health Club
GBHCs will be facilitated by trained Lay Health Counsellors (LHC). GBHCs will consist of a maximum 20 participants. GBHC sessions will held multiple times a month in each study area, allowing for flexibility for study participants. Sessions will be held at a safe and secure, centrally located area within the study community, and will be regularly monitored and assessed by the study coordinator. Participants will be invited to join a club-specific WhatsApp group to facilitate group communication and adherence support throughout the month. They will also be invited to partner up with another participant to provide mutual peer support. Permission will be sought from group-based adherence support participants before they are added to WhatsApp groups. Group adherence counsellors assigned will be members of WhatsApp groups, and will monitor all shared content to ensure that no inappropriate content or private information is shared in the group.

Experimental: One-on-one
One-on-one adherence counselling and support
Behavioral: Individual-based Adherence Support
IAS participants will be matched to a LHC and will schedule IAS sessions once-a-month for the duration of the study. These sessions will be held at a centralized location within the study community. The sessions will be semi-structured to allow for participant-driven discussion of any adherence challenges and key-messages. The adherence curriculum will also explore motivations for PrEP and adherence and focus on practical adherence tips, environmental cues, integration of PrEP within daily routines, short-term goal-setting, problem-solving, safe PrEP disclosure and social support, risk reduction counselling, partner communication, and HIV risk perception. A subset of IAS sessions will be audio-recorded for quality assurance by investigators and the study coordinator. These recordings are for training purposes only and will not form part of the dataset. Consent for recording IAS sessions will be sought from participants during the pre-enrolment consent process.

No Intervention: Medication pick-up
Community-based medication dispensary



Primary Outcome Measures :
  1. The cost per adolescent girl and young women on pre-exposure prophylaxis [ Time Frame: 10 months ]
    Itemized cost menus

  2. The incremental cost-effectiveness ratio per incidence HIV case averted [ Time Frame: 10 months ]
    Dynamic infectious disease model of HIV



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified as female (regardless of assigned sex at birth)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified as female (regardless of assigned sex at birth)
  • 16 - 25 years of age.
  • HIV negative (confirmed during CBCT testing)
  • At risk for HIV acquisition
  • Express interest in taking PrEP

Exclusion Criteria:

  • Planning to relocate in the next 12 months
  • Positive HIV test at screening or enrolment
  • Pregnant
  • Breastfeeding
  • Current participation in other HIV prevention studies (clinical or behavioural)
  • Current use of ARV drugs for post-exposure prophylaxis (PEP)
  • Presence of any disease or health condition, self-reported or identified by initiation clinician, that may prevent participation.

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): NCT03977181


Contacts
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Contact: Andrew Medina-Marino, PhD +27 (0) 128169000 AndrewM@foundation.co.za
Contact: Charl Bezuidenhout, M. Comm +27 (0) 871509279 CharlB@foundation.co.za

Locations
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South Africa
Buffalo City Metro Recruiting
East London, Eastern Cape, South Africa, 5217
Contact: Charl Bezuidenhout, M. Comm    +27 (0) 87 150 9279    CharlB@foundation.co.za   
Principal Investigator: Andrew Medina-Marino, PhD         
Principal Investigator: Linda-Gail Bekker, MBChB, PhD         
Sponsors and Collaborators
Foundation for Professional Development (Pty) Ltd
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Desmond Tutu HIV Centre
University of Washington
Investigators
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Principal Investigator: Andrew Medina-Marino, PhD Foundation for Professional Development
Principal Investigator: Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD Desmund Tutu HIV Centre

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Responsible Party: Foundation for Professional Development (Pty) Ltd
ClinicalTrials.gov Identifier: NCT03977181     History of Changes
Other Study ID Numbers: R01MH114648 ( U.S. NIH Grant/Contract )
1R01MH114648 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Access Criteria: Based on contractual agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation for Professional Development (Pty) Ltd:
PrEP
HIV Prevention
Adherence Support
Adolescence
South Africa