Participants' Explanations for Nonadherence in the FEM-PrEP Clinical Trial

Corneli, Amy; Perry, Brian D.; McKenna, Kevin; Agot, Kawango; Ahmed, Khatija; Taylor, Jamilah; Malamatsho, Fulufhelo; Odhiambo, Jacob; Skhosana, Joseph; Damme, Lut Van

doi:10.1097/qai.0000000000000880

Cited by 103 publications

(116 citation statements)

References 14 publications

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“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

Section: Resultsmentioning

confidence: 99%

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Day

Blumberg

et al. 2018

J Intern AIDS Soc

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IntroductionStakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to inform HIV clinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to the recommendations of the UNAIDS/AVAC Good Participatory Practice (GPP) guidelines.MethodsWe used the PRISMA checklist and identified English language studies describing stakeholder engagement to inform HIV clinical trials. Four databases (PubMed, Ovid, CINAHL and Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on the GPP guidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow‐up, results and dissemination.Results and discussionOf the 917 citations identified, 108 studies were included in the analysis. Forty‐eight studies (44.4%) described stakeholder engagement in high‐income countries, thirty (27.8%) in middle‐income countries and nine (8.3%) in low‐income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty‐five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engaging HIV‐affected community stakeholders (e.g. people living with HIV, at‐risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post‐trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%).ConclusionsOur findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages of HIV clinical trials compared to later stages. In order to meet recommendations established in the GPP guidelines, greater stakeholder engagement across all clinical trial stages is needed.

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Section: Resultsmentioning

confidence: 99%

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Day

Blumberg

et al. 2018

J Intern AIDS Soc

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“…Qualitative analyses showed that nonadherence to HIV-1 prophylaxis strategies in clinical trials may be related to characteristics of the participant (e.g., a younger age), the product (e.g., side effects), and the research process (e.g., concern about unproven safety and efficacy). 24,25 Notably, studies of the oral antiretroviral agent tenofovir have shown higher adherence in open-label studies after a demonstration of safety and efficacy than had been seen in the initial blinded, placebo-controlled trials. 26–28 …”

Section: Discussionmentioning

confidence: 99%

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Team¹

2016

N Engl J Med

640

598

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BACKGROUND Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. METHODS We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P = 0.05) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P = 0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, −133 to 31; P = 0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096.)

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“…Therefore, training providers to counsel about the benefits and risks is key to wide-scale implementation of PrEP, particularly in the context of combination HIV prevention. Although medical or research mistrust emerged as a less common theme in our study, which was conducted within an implementation study of a PrEP delivery model, as compared with PrEP clinical trials testing product efficacy [13,15,17], local ownership of PrEP implementation should help abate any perceptions of experimentation, racism or neocolonialism.…”

Section: Discussionmentioning

confidence: 99%

“Since both of us are using antiretrovirals, we have been supportive to each other”: facilitators and barriers of pre‐exposure prophylaxis use in heterosexual HIV serodiscordant couples in Kisumu, Kenya

Patel

Stanford-Moore

Odoyo

et al. 2016

Journal of the International AIDS Society

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IntroductionSince 2015, the World Health Organization recommends pre-exposure prophylaxis (PrEP) for all persons at substantial risk for HIV, including HIV-uninfected partners in serodiscordant relationships in resource-limited settings. As PrEP moves from clinical trials to real-world use, understanding facilitators of and barriers to PrEP initiation and adherence is critical to successful PrEP implementation and rollout.MethodsWe conducted 44 in-depth individual or couple interviews with 63 participants (30 without HIV and 33 with HIV) enrolled in the Partners Demonstration Project in Kisumu, Kenya, between August and September 2014. The semi-structured interviews discussed the following: 1) perceived advantages and disadvantages of antiretroviral therapy (ART)/PrEP; 2) reasons for accepting or declining ART/PrEP and 3) influence of prevention of transmission to partner or infant on ART/PrEP use. Transcripts from the interviews were iteratively analyzed using inductive content analysis.ResultsOur study identified three key factors that may facilitate initiation of PrEP in this population. First, participants using PrEP felt reduced stress and increased trust in their HIV serodiscordant relationships. Second, greater community-wide knowledge of PrEP was thought to likely increase PrEP acceptance. Third, greater education and counselling by providers on PrEP use was also considered to likely increase the adoption of PrEP. We also identified three key barriers to initiation of and adherence to PrEP. First, most participants who declined PrEP expressed doubts about the relative additional effectiveness of PrEP in combination with other prevention tools. Second, perceived stigma related to PrEP use was an important barrier to PrEP initiation. Third, many struggled with overcoming perceived side effects or logistical challenges of taking daily PrEP, particularly when they themselves were not ill.ConclusionsLeveraging the facilitators and overcoming barriers to PrEP uptake may enhance the successful rollout of PrEP among HIV serodiscordant couples in Kenya and other areas in sub-Saharan Africa, thereby reducing sexual transmission of HIV. Further research focused on how best to provide counselling on combination HIV prevention tools in the context of PrEP use is a crucial next step to delivering PrEP.

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Participants' Explanations for Nonadherence in the FEM-PrEP Clinical Trial

Cited by 103 publications

References 14 publications

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

“Since both of us are using antiretrovirals, we have been supportive to each other”: facilitators and barriers of pre‐exposure prophylaxis use in heterosexual HIV serodiscordant couples in Kisumu, Kenya

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