Trial reportJournal of the International AIDS Society2016
Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.
Trial report in Journal of the International AIDS Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00705679 (Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The effectiveness of tenofovir-based pre-exposure prophylaxis for prevention of HIV acquisition among sub-Saharan African women at high risk: a systematic review.The Pan African medical journal · 2021Pooled it
- The PrEP Care Continuum Among Cisgender Women Who Sell Sex and/or Use Drugs Globally: A Systematic Review.AIDS and behavior · 2020Pooled it
- Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.AIDS and behavior · 2024Trial
- Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use.AIDS and behavior · 2024Trial
- The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence.AIDS and behavior · 2021Trial
- Perspectives from Young South African and Zimbabwean Women on Attributes of Four (Placebo) Vaginal Microbicide Delivery Forms.AIDS and behavior · 2020Trial
- Young Women's Stated Preferences for Biomedical HIV Prevention: Results of a Discrete Choice Experiment in Kenya and South Africa.Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions.Journal of the International AIDS Society · 2019Trial
- Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE.AIDS and behavior · 2019Trial
- Pre-exposure Prophylaxis Outcomes from a Multilevel Cluster-Randomized Trial Among Adolescent Girls and Young Women in Tshwane, South Africa.AIDS and behavior · 2026Article
- Adherence to Oral HIV Pre-exposure Prophylaxis During Pregnancy and the Post-partum Period: Lessons Learned in an Open-Labelled Clinical Trial.AIDS and behavior · 2026Article
- Diverse Metrics of Success for Physician-Scientists: Reflections on My Path and the Evolving Role of the National Institute of Allergy and Infectious Diseases.The Journal of infectious diseases · 2025Article
- Effectiveness of a Community Empowerment Intervention to Improve Access to Pre-exposure Prophylaxis in Migrant Women Sex Workers: Protocol for a Mixed Methods Implementation Study.JMIR research protocols · 2023Article
- Cultivating PEARL (Promoting Empowerment and Risk Reduction): Formative Research for a PrEP Intervention Among Female Sex Workers in Baltimore, Maryland.AIDS and behavior · 2022Article
- Oral pre-exposure prophylaxis uptake, adherence, and adverse events among South African men who have sex with men and transgender women.Southern African journal of HIV medicine · 2022Article
- Characterization of Human Immunodeficiency Virus (HIV) Infection in Cisgender Men and Transgender Women Who Have Sex With Men Receiving Injectable Cabotegravir for HIV Prevention: HPTN 083.The Journal of infectious diseases · 2021Article
- Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.AIDS and behavior · 2021Article
- The paradox of HIV prevention: did biomedical prevention trials show how effective behavioral prevention can be?AIDS (London, England) · 2020Article
- The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa.BMC public health · 2020Article
- Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.Current HIV/AIDS reports · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
introductionIn the Microbicide Trial Network MTN-003 (VOICE) study, a Phase IIB pre-exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting.
methodsWe included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face-to-face interviews (FTFI), audio computer-assisted self-interviewing (ACASI) and pharmacy-returned product counts (PC). TFV concentrations < 0.31 ng/mL in plasma (oral group) and < 8.5 ng/swab in vaginal group were defined as "PK non-adherent." Logistic regression models were fit to calculate the combined predictive ability of the behavioural measures as summarized by area under the curve (AUC). Baseline characteristics associated with over-reporting daily product use relative to PK measures was assessed using a Generalized Linear Mixed Model.
resultsIn this random adherence cohort of VOICE participants assigned to active products, (N = 472), PK non-adherence was 69% in the oral group (N = 314) and 65% in the vaginal group (N = 158). Behaviourally, ≤ 10% of the cohort reported low/none use with any behavioural measure and accuracy was low (≤ 43%). None of the regression models had an AUC > 0.65 for any single or combined behavioural measures. Significant (p < 0.05) correlates of over-reporting included being very worried about getting HIV and being unmarried for the oral group; whereas for the vaginal group, being somewhat worried about HIV was associated with lower risk of over-reporting.
conclusionsPK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non-adherence. Accurate real-time measures to monitor product adherence are urgently needed.
trial registrationClinicalTrials.gov identifier: NCT00705679.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.