PrEPNCT03977181
The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms
A study testing Group-based Community Health Club and Individual-based Adherence Support in people with PrEP and HIV Prevention, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP, HIV Prevention, Adolescence
- What is being tested?
- Group-based Community Health Club and Individual-based Adherence Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Oct 2018to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa
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.
Read the 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.
- Conditions
- PrEP, HIV Prevention, Adolescence, Cost-effectiveness
- Being tested
- Group-based Community Health Club, Individual-based Adherence Support
- Keywords
- PrEP, HIV Prevention, Adherence Support, Adolescence, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Community Health ClubBehavioural
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.
Individual-based Adherence SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Club | Experimental | A group-based community health club akin to an ART adherence club Receives: Behavioral: Group-based Community Health Club |
| One-on-one | Experimental | One-on-one adherence counselling and support Receives: Behavioral: Individual-based Adherence Support |
| Medication pick-up | No intervention | Community-based medication dispensary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cost per adolescent girl and young women on pre-exposure prophylaxis
Itemized cost menus
Measured: 10 months
The incremental cost-effectiveness ratio per incidence HIV case averted
Dynamic infectious disease model of HIV
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start26 Oct 2018
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PrEPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Professional Development (Pty) Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Desmond Tutu HIV Centre, University of Washington
- Responsible party
- Sponsor
- Investigators
- Andrew Medina-Marino, PhD, Principal investigator, Foundation for Professional DevelopmentLinda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD, Principal investigator, Desmund Tutu HIV Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977181
- Sponsor's protocol ID
- R01MH114648
- Other IDs
- 1R01MH114648
- Status last verified
- Apr 2025
- First submitted
- 23 May 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
de Vos L, Krogstad Mudzingwa E, Fynn L, Atujuna M, Webb Mazinyo E, Kodi K, Hosek S, Katz IT, Celum C, Bekker LG, Daniels J, Medina-Marino A. Study-to-Clinic Transition and Daily Oral PrEP Access Experiences Among AGYW in Eastern Cape, South Africa: Insights from the Community PrEP Study. AIDS Behav. 2025 Aug;29(8):2574-2587. doi: 10.1007/s10461-025-04718-7. Epub 2025 Apr 17.
PubMed 40240718Krogstad Mudzingwa E, de Vos L, Atujuna M, Fynn L, Mugore M, Mabandla S, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa. J Behav Med. 2024 Apr;47(2):320-333. doi: 10.1007/s10865-023-00462-2. Epub 2023 Dec 11.
PubMed 38081955de Vos L, Mudzingwa EK, Fynn L, Atujuna M, Mugore M, Gandhi M, Celum C, Hosek S, Bekker LG, Daniels J, Medina-Marino A. Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. J Int AIDS Soc. 2023 Sep;26(9):e26175. doi: 10.1002/jia2.26175.
PubMed 37758649Mudzingwa EK, de Vos L, Atujuna M, Fynn L, Mugore M, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study. AIDS Behav. 2022 Nov;26(11):3726-3739. doi: 10.1007/s10461-022-03702-9. Epub 2022 Jun 2.
PubMed 35653046Medina-Marino A, Bezuidenhout D, Hosek S, Barnabas RV, Atujuna M, Bezuidenhout C, Ngwepe P, Peters RPH, Little F, Celum CL, Daniels J, Bekker LG. The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol. Trials. 2021 Jul 26;22(1):489. doi: 10.1186/s13063-021-05402-6.
PubMed 34311754
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa
- ClinicalTrials.gov ID
- NCT03977181
- Acronym / sponsor ID
- R01MH114648
- Conditions
- PrEP, HIV Prevention, Adolescence, Cost-effectiveness
- Keywords
- PrEP, HIV Prevention, Adherence Support, Adolescence, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Foundation for Professional Development (Pty) LtdUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Desmond Tutu HIV Centre, University of Washington
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Club | Experimental | Behavioral: Group-based Community Health ClubA group-based community health club akin to an ART adherence club |
| One-on-one | Experimental | Behavioral: Individual-based Adherence SupportOne-on-one adherence counselling and support |
| Medication pick-up | No intervention | –Community-based medication dispensary |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Community Health ClubGBHCs 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. | Behavioural | Health Club |
| Individual-based Adherence SupportIAS 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. | Behavioural | One-on-one |
Primary outcome
The cost per adolescent girl and young women on pre-exposure prophylaxis
Time frame: 10 months
Itemized cost menus
The incremental cost-effectiveness ratio per incidence HIV case averted
Time frame: 10 months
Dynamic infectious disease model of HIV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 40240718de Vos L, Krogstad Mudzingwa E, Fynn L, Atujuna M, Webb Mazinyo E, Kodi K, Hosek S, Katz IT, Celum C, Bekker LG, Daniels J, Medina-Marino A. Study-to-Clinic Transition and Daily Oral PrEP Access Experiences Among AGYW in Eastern Cape, South Africa: Insights from the Community PrEP Study. AIDS Behav. 2025 Aug;29(8):2574-2587. doi: 10.1007/s10461-025-04718-7. Epub 2025 Apr 17.
- Derived from this study: PubMed 38081955Krogstad Mudzingwa E, de Vos L, Atujuna M, Fynn L, Mugore M, Mabandla S, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa. J Behav Med. 2024 Apr;47(2):320-333. doi: 10.1007/s10865-023-00462-2. Epub 2023 Dec 11.
- Derived from this study: PubMed 37758649de Vos L, Mudzingwa EK, Fynn L, Atujuna M, Mugore M, Gandhi M, Celum C, Hosek S, Bekker LG, Daniels J, Medina-Marino A. Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. J Int AIDS Soc. 2023 Sep;26(9):e26175. doi: 10.1002/jia2.26175.
- Derived from this study: PubMed 35653046Mudzingwa EK, de Vos L, Atujuna M, Fynn L, Mugore M, Hosek S, Celum C, Bekker LG, Daniels J, Medina-Marino A. Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study. AIDS Behav. 2022 Nov;26(11):3726-3739. doi: 10.1007/s10461-022-03702-9. Epub 2022 Jun 2.
- Derived from this study: PubMed 34311754Medina-Marino A, Bezuidenhout D, Hosek S, Barnabas RV, Atujuna M, Bezuidenhout C, Ngwepe P, Peters RPH, Little F, Celum CL, Daniels J, Bekker LG. The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol. Trials. 2021 Jul 26;22(1):489. doi: 10.1186/s13063-021-05402-6.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Medina-Marino, PhD principal investigator
Foundation for Professional Development
Linda-Gail Bekker, MBChB, DTMH, DCH, FCP, PhD principal investigator
Desmund Tutu HIV Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Community Health Club and Individual-based Adherence Support in people with PrEP and HIV Prevention, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cost per adolescent girl and young women on pre-exposure prophylaxis (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977181, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.