Opics, participants’ reasons for taking the study pill.MethodsQualitative, semi-structured interviews

Opics, participants’ reasons for taking the study pill.MethodsQualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence Actinomycin IVMedChemExpress Actinomycin IV interview groups: “high,” “moderate,” and “none/scarce.” Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively.ResultsFive themes were identified from the SSIs as facilitating factors of adherence: 1) participants’ support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants’ adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94 , n = 161). We also found evidence of preventive misconception.PLOS ONE | DOI:10.1371/journal.pone.0125458 April 13,1 /Facilitators of Study Pill Adherence in FEM-PrEP09 00016-00. Early support was also provided by the Bill Melinda Gates Foundation. The drug concentration analyses were performed using equipment provided by the University of North Carolina at Chapel Hill Center for AIDS Research (CFAR), an NIH funded program P30 AI50410. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist.ConclusionsAdherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women.IntroductionFour randomized, double-blind, placebo-controlled clinical trials have demonstrated the efficacy of oral tenofovir disoproxil fumarate (TDF) or oral TDF combined with emtricitabine (FTC) as pre-exposure prophylaxis (PrEP) for the prevention of HIV [1?]. Two PrEP trials conducted among women in sub-Saharan Africa — FEM-PrEP and MTN-003 [Vaginal and Oral Interventions to Control the Epidemic (VOICE)] — did not demonstrate a reduction in HIV acquisition with oral FTC/TDF (FEM-PrEP and VOICE) or oral TDF (VOICE) [5,6]. FEM-PrEP was conducted in Bondo, Kenya; Bloemfontein and Pretoria, South Africa; and Arusha, Tanzania [5] (Belinostat site ClinicalTrials.gov Identifier: NCT00625404). Overall adherence to the study pill was observed to be low. After trial closure, an analysis of concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFV-DP) from specimens collected at each 4-week study visit among a randomized prospective sub-cohort of 150 FEM-PrEP participants demonstrated that 23 of participants rarely.Opics, participants’ reasons for taking the study pill.MethodsQualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: “high,” “moderate,” and “none/scarce.” Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively.ResultsFive themes were identified from the SSIs as facilitating factors of adherence: 1) participants’ support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants’ adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94 , n = 161). We also found evidence of preventive misconception.PLOS ONE | DOI:10.1371/journal.pone.0125458 April 13,1 /Facilitators of Study Pill Adherence in FEM-PrEP09 00016-00. Early support was also provided by the Bill Melinda Gates Foundation. The drug concentration analyses were performed using equipment provided by the University of North Carolina at Chapel Hill Center for AIDS Research (CFAR), an NIH funded program P30 AI50410. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist.ConclusionsAdherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women.IntroductionFour randomized, double-blind, placebo-controlled clinical trials have demonstrated the efficacy of oral tenofovir disoproxil fumarate (TDF) or oral TDF combined with emtricitabine (FTC) as pre-exposure prophylaxis (PrEP) for the prevention of HIV [1?]. Two PrEP trials conducted among women in sub-Saharan Africa — FEM-PrEP and MTN-003 [Vaginal and Oral Interventions to Control the Epidemic (VOICE)] — did not demonstrate a reduction in HIV acquisition with oral FTC/TDF (FEM-PrEP and VOICE) or oral TDF (VOICE) [5,6]. FEM-PrEP was conducted in Bondo, Kenya; Bloemfontein and Pretoria, South Africa; and Arusha, Tanzania [5] (ClinicalTrials.gov Identifier: NCT00625404). Overall adherence to the study pill was observed to be low. After trial closure, an analysis of concentrations of plasma tenofovir (TFV) and intracellular tenofovir diphosphate (TFV-DP) from specimens collected at each 4-week study visit among a randomized prospective sub-cohort of 150 FEM-PrEP participants demonstrated that 23 of participants rarely.

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