Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302499607694 Date of Registration: 14/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PrEPared to Choose
Official scientific title Delivery of Cabotegravir LA Injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within the Fast-PrEP project.
Brief summary describing the background and objectives of the trial Pre-exposure prophylaxis (PrEP) for HIV prevention has the potential to diminish HIV acquisition amongst high-risk groups. Oral Tenofovir-based PrEP formulations have been approved in South Africa since 2016, however, uptake, adherence, and persistent on oral PrEP, especially among young populations, has been an ongoing challenge. With the recent SAHPRA approval of new long-acting PrEP formulations, specifically a Dapivirine vaginal ring (approved March 2022) and Cabotegravir injectable PrEP (approved December 2022), there is now opportunity to offer PrEP choice to individuals at high-risk of HIV infection who may otherwise struggle with a daily pill regimen. The PrEPared to Choose trial is a sub-study within a large study called FAST-PrEP, which is an implementation science project to evaluate uptake, coverage and effectiveness of a youth-focussed, decentralized district-wide PrEP program in Cape Town, South Africa. Adolescents and young people aged 15-29 years, recruited from public health facilities and mobile clinics operating in the study area, will be invited to participate in the sub-study. These participants will be provided with PrEP Choice counselling sessions at baseline and every subsequent study visit and invited to choose between three PrEP products (oral PrEP, injectable PrEP, or a vaginal PrEP ring). The aim of the study is to assess relative persistence on PrEP amongst young people (aged 15-29 years) selecting CAB LA vs other PrEP modalities.The primary objectives of the study are (1) to compared short-term (6 month) persistence across PrEP modalities and across different young population groups and (2) to determine what combination of implementation strategies best achieve PrEP adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (6 months) and the long term (18 months).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/06/2023
Actual trial start date
Anticipated date of last follow up 01/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1800
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cabotegravir Long acting 1x 3ml gluteal intra-muscular injection of 600mg Cabotegravir every 8 weeks. The duration of protection is 8 weeks. Participants will be offered a choice between all three PrEP options (injectable, oral, or vaginal ring). Participants that select to use the injectable PrEP option will be administered a Cabotegravir injection once every eight weeks by a trained healthcare provider from a local health facility or mobile service over an 18 month period. Participants will undergo HIV testing at each visit, prior to administration of the next injection. Participants will be able to switch to using oral or vaginal PrEP at every study visit (eight week interval). Uptake and persistence on injectable PrEP will be monitored. Implementation strategies to optimise PrEP use at the level of PrEP user and the PrEP provider will be trialled and optimised across the 18 month period. 900
Experimental Group Dapivirine Vaginal PrEP Ring A Dapivirine containing ring that is inserted intra-vaginally. Duration of protection is 28 days. Participants will be counseled on PrEP choice across the three products. Those that select to use the vaginal ring will have one inserted intra-vaginally by a healthcare provider and taught how to self-insert and remove the ring. Participants can collect a monthly replacement from public health facilities, mobile services, select community sites, or request courier delivery. Participants will be allowed to switch from the ring to an injectable or oral form of PrEP at any study visit. Participants will be required to undergo HIV testing monthly (either at a facility or using home self-testing kits). 300
Control Group Oral PrEP Tenofovir-containing pill taken once daily. Provides protection from HIV infection for 1 day (24 hours). A monthly supply of daily pills is provided at each study visit. Participants will be counseled on PrEP choice across the three products. Those that select to use oral PrEP will be provided with a one month supply of oral PrEP pills (1 PrEP bottle). Participants can collect a monthly bottle replacement from public health facilities, mobile services, select community sites, or request courier delivery. Participants will be allowed to switch from the ring to an injectable or oral form of PrEP at any study visit. Participants will be required to undergo HIV testing monthly (either at a facility or using home self-testing kits). 600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 15-29 years Member of a target population: adolescent girls and young women, young key populations (young people who trade sex; young gender and sexually diverse populations), or intimate partners of these populations. Pregnant and breastfeeding women HIV negative Body weight >= 35 kg at baseline Currently residing in the study criteria Able to provide written, informed voluntary consent to partake in the study and willing Able to receive a PrEP product Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection Weight <35kg Clinical conditions - pregnant women cannot use the vaginal ring; individuals with inflammatory skin conditions that could compromise the safety of an intramuscular injection. Allergy to any of the study products Use of contraindicated medications (e.g. Rifampicin should not be co-administered with CAB-LA). Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in study visits for geographical reasons, according to the site investigator Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records) Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 15 Year(s) 29 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 18/01/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Floor E53, Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare short term persistence across PrEP modalities overall and across different young population groups. 6 months
Primary Outcome To determine what combination of implementation strategies best achieve PrEP adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (6 months) and the long term (18 months). 6 and 18 months
Secondary Outcome To compare durable persistence across PrEP modalities overall and across different young population groups 18 months
Secondary Outcome Time on PrEP based on expected vs. actual PrEP coverage based on oral/vaginal PrEP collection and injections. 6 and 18 months
Secondary Outcome To describe the safety, tolerability, and acceptance of all three methods, determined by self-reported adverse side effects, adverse events (including intimate partner violence), and reasons for PrEP pause or discontinuation. 6 and 18 months
Secondary Outcome An exploratory aim will be to describe and compare HIV incidence across the three PrEP modality arms. The sample size of the study is insufficient to allow for a formal analysis of these outcomes. Resistance testing will be conducted for all participants that sero-convert while initiated on any PrEP product. 6 and 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Desmond Tutu Health Foundation 3 Woodlands Rd, Woodstock Cape Town 7915 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 5th Ave N Seattle WA98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Desmond Tutu Health Foundation 3 Woodlands Rd, Woodstock Cape Town 7915 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Linda Gail Bekker Linda-Gail.Bekker@hiv-research.org.za +27213012049 3 Woodlands Rd, Woodstock
City Postal code Country Position/Affiliation
Cape Town South Africa Director
Role Name Email Phone Street address
Public Enquiries Carey Pike Carey.Pike@hiv-research.org.za +27844532928 3 Woodlands Rd, Woodstock
City Postal code Country Position/Affiliation
Cape Town South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Carey Pike Carey.Pike@hiv-research.org.za 27844532928 3 Woodlands Rd, Woodstock
City Postal code Country Position/Affiliation
Cape Town South Africa Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study Protocol Beginning 12 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Data can be used for individual participant meta-analysis. A proposal may be submitted up to 36 months following article publication. After 36 months the data will be available in out University’s data warehouse but without investigator support other than deposited metadata.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information