HIVPhase 4NCT02732730
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
A Phase 4 study testing Truvada and Drug level counseling at Weeks 8 and 13 in people with HIV, run by HIV Prevention Trials Network at 3 sites in 2 countries.
Trial summary
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women. 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
- HIV
- What is being tested?
- Truvada and Drug level counseling at Weeks 8 and 13
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Oct 2016to 25 Oct 2018
- Phase
- Phase 4
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
- Young women who meet all of the following criteria are eligible for inclusion in this study:
- Female at birth
- Age 16-25 years
- Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
- Literate in one or more of the study languages
- Willing and able to provide informed consent or assent (if parental consent is required per local regulations)
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- If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing
- Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs)
- Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool
- Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures [SSP] Manual)
- Regular access to a mobile phone with SMS capacity
- Agrees not to participate in other research studies involving drugs or medical devices for the next 12 months
- Hepatitis B virus (HBV) seronegative and accepts HBV vaccination.
Who cannot join
- Young women who meet any of the following criteria will be excluded from this study:
- Planning to relocate in the next 12 months
- Has a job or other obligations that would require long absences from the area (> 4 weeks at a time) for 12 months
- Any health condition that may interfere with participation, including any debilitating or life-threatening conditions
- Currently pregnant or planning to become pregnant in the next 12 months
- Any reactive or positive HIV test at Screening or Enrollment, even if subsequent testing indicates that the person is HIV-uninfected
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- Renal dysfunction (Creatinine Clearance < 60 ml/min, Schwartz Equation)
- Any reported PrEP use within the last 12 months
- Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
- Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
- Signs or symptoms of acute HIV infection (as described in the SSP Manual)
- Current active and serious infections which could interfere with study participation, including active tuberculosis infection, osteomyelitis, and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly-controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment.
- Current use of ARV drugs for post-exposure prophylaxis (PEP) or completion of a PEP regimen within 4 weeks prior to Screening
- History of pathological bone fracture not related to trauma
- Known allergy/sensitivity to the study drug or its components
- Receiving ongoing therapy with any of the following: investigational ARV agents, interferon or interleukin therapy, agents with substantial nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
- Any other condition that, based on the opinion of the site Investigator of Record (IoR) or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
Emavundleni CRS
Cape Town, Western Cape, 7750
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, 2001
About this study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
Read the detailed description
A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to ~25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.
- Conditions
- HIV
- Being tested
- Truvada, Drug level counseling at Weeks 8 and 13
- Keywords
- ART (Antir-retroviral therapy), PrEP (Pre-Exposure Prophylaxis), DAIDS (Division of AIDS), HPTN (HIV Prevention Trials Network)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called PrEP Acceptor
400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13Behavioural
Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Adherence Support | Experimental | For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs
* Drug level counseling at Weeks 8 and 13 Receives: Drug: Truvada; Behavioral: Drug level counseling at Weeks 8 and 13 |
| Standard Adherence Support | Active comparator | For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
* Cognitive Behavioral Theory adherence support sessions
* Two-way SMS communications
* Optional monthly adherence support clubs Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With High Adherence at Six Months
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Measured: at month 6 from start of the study
Secondary outcomes (1)
Number of Participants With High Adherence at Twelve Months
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Measured: 12 months from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start12 Oct 2016
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institutes of Health (NIH), Gilead Sciences, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Connie Celum, MD, MPH, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732730
- Sponsor's protocol ID
- HPTN 082
- Other IDs
- UM1AI068619, 12068
- Status last verified
- Jun 2025
- First submitted
- 2 Mar 2016
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be pooled by PID for central analysis by the Fred Hutch in Seattle, Washington
Publications
Magongo M, Mhlanga N, Nobanda S, Chasakara C, Yola N, Hinson K, Bryan M, Mzizi P, Essien T, Hastings N, Ndimande-Khoza MN, Bekker LG, Mgodi N, Celum C, Delany-Moretlwe S. Engagement of adolescent girls and young women into an early oral PrEP open-label study in Southern Africa: lessons learned from HPTN 082. BMC Public Health. 2025 Nov 17;25(1):3982. doi: 10.1186/s12889-025-24890-8.
PubMed 41249973Ssemambo PK, Burton M, Mirembe BG, Nakabiito C, Donnell D, Beauchamp G, Delany-Moretlwe S, Celum C, Velloza J. Correlates of long-acting reversible contraceptive (LARC) use among young women in Southern Africa: a secondary analysis from HPTN 082. medRxiv [Preprint]. 2025 Sep 18:2025.09.16.25335943. doi: 10.1101/2025.09.16.25335943.
PubMed 41001449Magongo M, Mhlanga N, Nobanda S, Chasakara C, Yola N, Hinson K, Bryan M, Mzizi P, Essien T, Hastings N, Ndimande-Khoza MN, Bekker LG, Mgodi N, Celum C, Delany-Moretlwe S. Recruitment of Adolescent Girls and Young Women into an Early Oral PrEP Open- Label Study in Southern Africa: Lessons Learned from HPTN 082. Res Sq [Preprint]. 2025 Mar 28:rs.3.rs-5084642. doi: 10.21203/rs.3.rs-5084642/v1.
PubMed 40196011Beauchamp G, Hosek S, Donnell D, Chan KCG, Anderson PL, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study team. The Effect of Disclosure of PrEP Use on Adherence Among African Young Women in an Open-Label PrEP Study: Findings from HPTN 082. AIDS Behav. 2024 May;28(5):1512-1521. doi: 10.1007/s10461-023-04175-0. Epub 2023 Sep 28.
PubMed 37768427Beauchamp G, Donnell D, Hosek S, Anderson PL, Chan KCG, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C. Trust in the provider and accurate self-reported PrEP adherence among adolescent girls and young women in South Africa and Zimbabwe: HPTN 082 study. BMC Womens Health. 2023 May 19;23(1):276. doi: 10.1186/s12905-023-02418-9.
PubMed 37208687Delany-Moretlwe S, Mgodi N, Bekker LG, Baeten JM, Li C, Donnell D, Agyei Y, Lennon D, Rose SM, Mokgatle M, Kassim S, Mukaka S, Adeyeye A, Celum C. High prevalence and incidence of gonorrhoea and chlamydia in young women eligible for HIV pre-exposure prophylaxis in South Africa and Zimbabwe: results from the HPTN 082 trial. Sex Transm Infect. 2023 Nov;99(7):433-439. doi: 10.1136/sextrans-2022-055696. Epub 2023 Mar 8.
PubMed 36889914Beauchamp G, Hosek S, Donnell DJ, Chan KCG, Flaherty BP, Anderson PL, Dye BJ, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study team. Development of a tool to assess HIV prevention readiness of adolescent girls and young women in HPTN 082 study. PLoS One. 2023 Feb 24;18(2):e0281728. doi: 10.1371/journal.pone.0281728. eCollection 2023.
PubMed 36827440Velloza J, Donnell D, Hosek S, Anderson PL, Chirenje ZM, Mgodi N, Bekker LG, Marzinke MA, Delany-Moretlwe S, Celum C. Alignment of PrEP adherence with periods of HIV risk among adolescent girls and young women in South Africa and Zimbabwe: a secondary analysis of the HPTN 082 randomised controlled trial. Lancet HIV. 2022 Oct;9(10):e680-e689. doi: 10.1016/S2352-3018(22)00195-3. Epub 2022 Sep 7.
PubMed 36087612Velloza J, Hosek S, Donnell D, Anderson PL, Chirenje M, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study group. Assessing longitudinal patterns of depressive symptoms and the influence of symptom trajectories on HIV pre-exposure prophylaxis adherence among adolescent girls in the HPTN 082 randomized controlled trial. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25731. doi: 10.1002/jia2.25731.
PubMed 34164929Celum C, Hosek S, Tsholwana M, Kassim S, Mukaka S, Dye BJ, Pathak S, Mgodi N, Bekker LG, Donnell DJ, Wilson E, Yuha K, Anderson PL, Agyei Y, Noble H, Rose SM, Baeten JM, Fogel JM, Adeyeye A, Wiesner L, Rooney J, Delany-Moretlwe S. PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: Results from HPTN 082, a randomized controlled trial. PLoS Med. 2021 Jun 18;18(6):e1003670. doi: 10.1371/journal.pmed.1003670. eCollection 2021 Jun.
PubMed 34143779Velloza J, Khoza N, Scorgie F, Chitukuta M, Mutero P, Mutiti K, Mangxilana N, Nobula L, Bulterys MA, Atujuna M, Hosek S, Heffron R, Bekker LG, Mgodi N, Chirenje M, Celum C, Delany-Moretlwe S; HPTN 082 study group. The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study. J Int AIDS Soc. 2020 Mar;23(3):e25463. doi: 10.1002/jia2.25463.
PubMed 32144874