HIVNCT06176859
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
A study testing HIV PrEP Delivery in people with HIV and Human Immunodeficiency Virus, run by Massachusetts General Hospital at 1 site in South Africa.
Trial summary
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Human Immunodeficiency Virus, ART
- What is being tested?
- HIV PrEP Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Jul 2023to 26 Mar 2026
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 16 years - 30 years old,
- Self-report living without HIV or unknown status.
- Persons who have been sexually active within the last 3 months
- Interested in the use of PrEP for HIV prevention.
- Able and willing to provide informed consent for study procedures.
- Access to a cellphone for study related communication
- Reside in the study community for the duration of follow-up.
Who cannot join
- HIV infection based on negative HIV rapid tests
- Clinically ineligible for PrEP
- The participant doesn't reside in the study community for the duration of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study: A Prospective, Interventional, Randomized Study of Community-based PrEP Initiation, Delivery, and Monitoring in South Africa
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
Read the detailed description
Optimizing pre-exposure prophylaxis (PrEP) delivery with a focus on priority populations is critical to realize the enormous potential of PrEP for HIV prevention. HIV incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the HIV epidemic. With effective and persistent use, oral pre-exposure prophylaxis (PrEP) for HIV prevents 75%-100% of HIV cases among cisgender women and men, gay and bisexual men, and transgender women. Despite the high efficacy, uptake throughout the PrEP prevention cascade remains low.
South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access, effective use, and persistence. The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation, monitoring and refills. Barriers to PrEP access include clinic level factors (i.e. staff training, brief visits) and individual level factors including logistics such as transportation for clinic visits. The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective, persistent use.
PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up. Community-based strategies for HIV testing, ART initiation, and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression.
This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP. It aims to safely increase PrEP access and use among priority populations in South Africa. Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV. As a critical component of decentralized delivery, we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests.
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Being tested
- HIV PrEP Delivery
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV PrEP DeliveryOther
To test an end-to-end decentralized delivery service for pre-exposure prophylaxis (PrEP) to safely increase PrEP access and use among priority populations in South Africa.
| Study group | Role | What they receive |
|---|---|---|
| Home-based PrEP | Experimental | In the home-based PrEP arm, participants will complete the HIV self-test at home with support received through telemedicine or over the phone. Confirmation of HIV test result will be shared with the provider through a photograph of the test. PrEP refills will be delivered to participants at home by courier. Receives: Other: HIV PrEP Delivery |
| Community-based PrEP | Active comparator | In the community-based PrEP arm, participants will be tested using rapid diagnostic tests (RDT) in person (at a community venue) or through telemedicine (at a community venue) where they will be linked by counsellor telephonically to nurse or clinician. PrEP refills will be collected by participants at a community venue. Receives: Other: HIV PrEP Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) .
The proportion of study participants who effectively accessed PrEP and continued use over a 12-month period.
Measured: 36 Months
Secondary outcomes (3)
The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation.
To compare the safety and efficacy of HIV self-testing (HIVST) to rapid diagnostic tests (RDT) by comparing the sensitivity and specificity of each diagnostic test.
Measured: 36 Months
Persistent use of PrEP over a 12-month period.
The proportion of study participants in the home-monitored arm who accessed and effectively/persistently used PrEP over a 12-month period compared to the community-monitored arm.
Measured: 36 Months
Cost effectiveness per HIV incident averted.
Estimate the incremental cost-per-person receiving community-based PrEP.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start17 Jul 2023
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, interventional, and randomized study
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Ruanne Barnabas, MBChB, MSc, DPhil., Massachusetts General Hospital
- Investigators
- Zaynab Essack, PhD, Principal investigator, Human Sciences Research Council of South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176859
- Sponsor's protocol ID
- 2022P003023
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study: A Prospective, Interventional, Randomized Study of Community-based PrEP Initiation, Delivery, and Monitoring in South Africa
- ClinicalTrials.gov ID
- NCT06176859
- Acronym / sponsor ID
- 2022P003023
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 20 Dec 2023 (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 overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
Detailed description
Optimizing pre-exposure prophylaxis (PrEP) delivery with a focus on priority populations is critical to realize the enormous potential of PrEP for HIV prevention. HIV incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the HIV epidemic. With effective and persistent use, oral pre-exposure prophylaxis (PrEP) for HIV prevents 75%-100% of HIV cases among cisgender women and men, gay and bisexual men, and transgender women. Despite the high efficacy, uptake throughout the PrEP prevention cascade remains low.
South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access, effective use, and persistence. The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation, monitoring and refills. Barriers to PrEP access include clinic level factors (i.e. staff training, brief visits) and individual level factors including logistics such as transportation for clinic visits. The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective, persistent use.
PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up. Community-based strategies for HIV testing, ART initiation, and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression.
This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP. It aims to safely increase PrEP access and use among priority populations in South Africa. Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV. As a critical component of decentralized delivery, we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, interventional, and randomized study
| Arm | Type | Receives |
|---|---|---|
| Home-based PrEP | Experimental | Other: HIV PrEP DeliveryIn the home-based PrEP arm, participants will complete the HIV self-test at home with support received through telemedicine or over the phone. Confirmation of HIV test result will be shared with the provider through a photograph of the test. PrEP refills will be delivered to participants at home by courier. |
| Community-based PrEP | Active comparator | Other: HIV PrEP DeliveryIn the community-based PrEP arm, participants will be tested using rapid diagnostic tests (RDT) in person (at a community venue) or through telemedicine (at a community venue) where they will be linked by counsellor telephonically to nurse or clinician. PrEP refills will be collected by participants at a community venue. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 16 years - 30 years old,
- Self-report living without HIV or unknown status.
- Persons who have been sexually active within the last 3 months
- Interested in the use of PrEP for HIV prevention.
- Able and willing to provide informed consent for study procedures.
Key exclusion criteria (3 listed)
- HIV infection based on negative HIV rapid tests
- Clinically ineligible for PrEP
- The participant doesn't reside in the study community for the duration of follow-up
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 |
|---|---|---|
| HIV PrEP DeliveryTo test an end-to-end decentralized delivery service for pre-exposure prophylaxis (PrEP) to safely increase PrEP access and use among priority populations in South Africa. | Other | Community-based PrEP, Home-based PrEP |
Primary outcome
The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) .
Time frame: 36 Months
The proportion of study participants who effectively accessed PrEP and continued use over a 12-month period.
3 secondary outcomes
The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation.
Time frame: 36 Months
Persistent use of PrEP over a 12-month period.
Time frame: 36 Months
Cost effectiveness per HIV incident averted.
Time frame: 36 Months
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 10 Jul 2026.
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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.
Zaynab Essack, PhD principal investigator
Human Sciences Research Council of South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV PrEP Delivery in people with HIV and Human Immunodeficiency Virus, run by Massachusetts General Hospital 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 7 inclusion and 3 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 10 Jul 2026. 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 primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) . (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.