Disclosure of Pharmacokinetic (PK) Drug Results Promotes Open Discourse on Non-adherence among Women in VOICE

StratenAriane, van der; MusaraPetina,; EtimaJuliane,; WoeberKubashni,; MontgomeryElizabeth, T; HartmannMiriam,; LevyLisa,; BennyThola,; ChengHelen,; PiperJeanna,; GrossmanCynthia, I; MenschBarbara,

doi:10.1089/aid.2014.5071.abstract

Cited by 7 publications

(9 citation statements)

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“…Findings from these studies may inform the development of new multi-level strategies that provide long term support for achieving and maintaining optimal adherence in future PrEP trials and demonstration projects. VOICE D, an ancillary study, investigated the contextual and trial-specific issues influencing actual and reported product use and sexual behaviors during women’s participation in VOICE [30]. …”

Section: Medication Adherencementioning

confidence: 99%

“…Interestingly, the Partners PrEP study reported that condom use increased during the study follow up period [2]. Given that current PrEP strategies are not completely effective [33], and are not protective against other sexually transmitted infections [30, 36], adequate behavioral change interventions should also be implemented to ensure that risk compensation does not occur in PrEP users. Individuals using PrEP should be provided with intensive ongoing education and counseling emphasizing the importance of condom use and safe sexual behavior.…”

Section: Behavioral Disinhibition/risk Compensationmentioning

confidence: 99%

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The current status of the use of oral medication to prevent HIV transmission

Mayer

Ramjee

2015

Current Opinion in HIV and AIDS

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Purpose of review This review was designed to evaluate the progress in studies of the use of oral and topical antiretroviral medication for primary HIV prevention. Recent findings Non-human primate data has suggested that the administration of antiretroviral medication before or after retroviral exposure can protect against the establishment of chronic infection. Over the past two decades, observational studies have demonstrated the safety of antiretroviral agents for post-exposure prophylaxis (PEP) and more recent efficacy studies have demonstrated that tenofovir with or without emtricitabine can protect against HIV when used as pre-exposure prophylaxis (PrEP). Efficacy studies have been conducted in diverse populations, including men and transgender women who have sex with men, young African heterosexuals, and injection drug users. Three studies in African women evaluating oral and topical tenfovir-based regimens did not demonstrate efficacy, in large part because of suboptimal medication adherence. Further research is underway to determine the optimal ways to provide chemoprophylaxis, the optimal medications, and dosing regimens. Summary PrEP can be effective in decreasing HIV transmission to at risk uninfected persons, but further research is needed to determine the optimal modes of delivery.

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Section: Medication Adherencementioning

confidence: 99%

Section: Behavioral Disinhibition/risk Compensationmentioning

confidence: 99%

The current status of the use of oral medication to prevent HIV transmission

Mayer

Ramjee

2015

Current Opinion in HIV and AIDS

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“…Preliminary results from VOICE D, an ancillary study to explore participant’s adherence challenges during the VOICE trial, corroborated these findings of product sharing [32]. Participants in VOICE D reported sharing with their family or friends who wanted to use the study product.…”

Section: Discussionmentioning

confidence: 77%

“…Participants may count and dispose of surplus unused study product, or may not return any unused study product if they were intentionally sharing study product, in order to appear adherent [32]. As a result the exact number of product sharing incidents at the SAMRC Durban sites is not known and could be much higher than estimated by pharmacists.…”

Section: Discussionmentioning

confidence: 99%

Sharing of Investigational Drug Among Participants in the Voice Trial

et al. 2016

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Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting.

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“…Qualitative research performed in the VOICE and FEM-PrEP participants posttrial indicated that even in places in which HIV transmission is rampant, women at risk are more interested in obtaining contraception than in obtaining biomedical products aimed solely at HIV prevention. 12 Several concepts concerning the use of an intravaginal ring that delivers combined antiretroviral and contraception agents are being studied. 13 Results of the first phase 3 clinical trial using a silicone intravaginal ring to deliver dapivirine, the ASPIRE Study, will be essential to inform how this agenda moves forward.…”

mentioning

confidence: 99%

A Shot in the Arm for HIV Prevention? Recent Successes and Critical Thresholds

Hope

Marrazzo

2015

AIDS Research and Human Retroviruses

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Efforts to decrease the spread of HIV worldwide continue at a rapid pace. With the development of new biomedical interventions and findings from pivotal clinical trials, a new framework for short-term and long-term prevention strategies is emerging. It is clear that biomedical-based approaches targeted at the highest risk populations have the greatest potential to have a short-term impact. Unfortunately, challenges with adherence in healthy populations at risk are now well-recognized, and competing health care priorities in the context of fragile delivery infrastructures pose formidable obstacles to implementation. We need better ways to identify high-risk populations, sophisticated understanding of the behavioral parameters that can ensure adherence, and the development of better strategies to provide sustained delivery of preexposure prophylaxis (PrEP). In the long term, we need an effective vaccine-a path that has proven to be rocky. Research facilitating an increased understanding of immune responses and what represents effective responses to prevent HIV acquisition should facilitate progress. While we wait for that time, PrEP offers the best strategy for short-term impact.

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Disclosure of Pharmacokinetic (PK) Drug Results Promotes Open Discourse on Non-adherence among Women in VOICE

Cited by 7 publications

References 0 publications

The current status of the use of oral medication to prevent HIV transmission

The current status of the use of oral medication to prevent HIV transmission

Sharing of Investigational Drug Among Participants in the Voice Trial

A Shot in the Arm for HIV Prevention? Recent Successes and Critical Thresholds

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