Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
NCT ID: NCT02732730
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
451 participants
INTERVENTIONAL
2016-10-12
2018-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enhanced Adherence Support
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
Truvada
400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13
Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
Standard Adherence Support
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
Truvada
400 women who accept to initiate PrEP
Interventions
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Truvada
400 women who accept to initiate PrEP
Drug level counseling at Weeks 8 and 13
Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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.
16 Years
25 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Gilead Sciences
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
HIV Prevention Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Connie Celum, MD, MPH
Role: STUDY_CHAIR
University of Washington
Locations
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Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, South Africa
Emavundleni CRS
Cape Town, Western Cape, South Africa
Spilhaus CRS
Harare, Belgravia, Zimbabwe
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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12068
Identifier Type: OTHER
Identifier Source: secondary_id
HPTN 082
Identifier Type: -
Identifier Source: org_study_id
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