Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

NCT02732730 | Completed Phase 4 Results DMC

• 3 other identifiers: HPTN 082UM1AI06861912068
• Study Type: interventional
• Target: 451
• Locations: 2 countries
• Sites: 3

Brief Summary

To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

Conditions

HIV

Keywords

ART (Antir-retroviral therapy); PrEP (Pre-Exposure Prophylaxis); DAIDS (Division of AIDS); HPTN (HIV Prevention Trials Network)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With High Adherence at Six Months

  Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch

  at month 6 from start of the study

Secondary Outcomes (1)

• Number of Participants With High Adherence at Twelve Months

  12 months from the start of the study

Study Arms (2)

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

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

Drug: Truvada

Interventions

Truvada DRUG

400 women who accept to initiate PrEP

Also known as: PrEP Acceptor

Enhanced Adherence Support; Standard Adherence Support

Drug level counseling at Weeks 8 and 13 BEHAVIORAL

Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance

Enhanced Adherence Support

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institutes of Health (NIH): collaborator
• Gilead Sciences: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Wits Reproductive Health and HIV Institute

Johannesburg, Gauteng, 2001, South Africa

Location

Emavundleni CRS

Cape Town, Western Cape, 7750, South Africa

Location

Spilhaus CRS

Harare, Belgravia, 306, Zimbabwe

Location

Related Publications (11)

• 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.

  PMID: 41249973 DERIVED

• Ssemambo 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.

  PMID: 41001449 DERIVED

• 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. 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.

  PMID: 40196011 DERIVED

• Beauchamp 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.

  PMID: 37768427 DERIVED

• Beauchamp 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.

  PMID: 37208687 DERIVED

• Delany-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.

  PMID: 36889914 DERIVED

• Beauchamp 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.

  PMID: 36827440 DERIVED

• Velloza 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.

  PMID: 36087612 DERIVED

• Velloza 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.

  PMID: 34164929 DERIVED

• Celum 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.

  PMID: 34143779 DERIVED

• Velloza 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.

  PMID: 32144874 DERIVED

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

There was very little community awareness about PrEP at the time of this study, which may have impacted adherence and persistence. We did not have the power to detect a modest effect of retrospective drug level feedback on subsequent PrEP adherence. There was not a placebo control to ethical concerns about withholding an effective intervention, so the contribution of PrEP to the low HIV incidence cannot be determined.

Results Point of Contact

• Title: HPTN Statistical Manager
• Organization: HPTN Statistical & Data Management Center

HPTN-Data-Access@scharp.org

206-667-4004

Study Officials

• Connie Celum, MD, MPH

  University of Washington

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 11, 2016
• Study Start: October 12, 2016
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1); ZA (2)