Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers

University of Cape Town, South Africa
PLoS ONE (Impact Factor: 3.23). 04/2012; 7(4):e33103. DOI: 10.1371/journal.pone.0033103
Source: PubMed


Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW).
MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.
Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens. NCT00971230.

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    • "Because of this, additional prevention modes such as pre/post-exposure prophylaxis, and treatment for those living with HIV (FSW, their clients and partners) can provide protection against acquisition and transmission of HIV and/or STI to or from clients or nonpaying partners. Because there are relatively few studies of pre-exposure prophylaxis among FSW (Mutua et al., 2012; Singh & Mills, 2005; Vissers et al., 2008 "
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    ABSTRACT: Objectives. This study examined correlates of condom use among 248 female sex workers (FSW) in The Gambia. Methods. Between July and August 2011, FSW in The Gambia who were older than 16 years of age, the age of consent in The Gambia, were recruited for the study using venue-based sampling and snowball sampling, beginning with seeds who were established clients with the Network of AIDS Services Organizations. To be eligible, FSW must have reported selling sex for money, favors, or goods in the past 12 months. Bivariate and multivariate logistic regressions were used to determine associations and the relative odds of the independent variables with condom use. Four different condom use dependent variables were used: consistent condom use in the past six months during vaginal or anal sex with all clients and partners; consistent condom use in the past month during vaginal sex with new clients; consistent condom use in the past month during vaginal sex with nonpaying partners (including boyfriends, husbands, or casual sexual partners); and condom use at last vaginal or anal sex with a nonpaying partner. Results. Many FSW (67.34%, n = 167) reported it was not at all difficult to negotiate condom use with clients in all applicable situations, and these FSW were more likely to report consistent condom use with all clients and partners in the past 6 months (aOR 3.47, 95% CI [1.70-7.07]) compared to those perceiving any difficulty in condom negotiation. In addition, FSW were more likely to report using condoms in the past month with new clients (aOR 8.04, 95% CI [2.11-30.65]) and in the past month with nonpaying partners (aOR 2.93, 95% CI [1.09-7.89]) if they had been tested for HIV in the past year. Women who bought all their condoms were less likely than those who received all of their condoms for free (aOR 0.38, 95% CI [0.15-0.97]) to have used a condom at last vaginal or anal sex with a nonpaying partner. Conclusions. HIV and sexually transmitted infection (STI) prevention interventions for FSW should aim to improve condom negotiation self-efficacy since women who report less difficulty negotiating condom use are more likely to use condoms with clients. Interventions should also be aimed at structural issues such as increasing access to free condoms and HIV testing since these were positively associated with condom use among FSW.
    PeerJ 08/2015; 3(2):e1076. DOI:10.7717/peerj.1076 · 2.11 Impact Factor
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    • "Sexual strategies include considering HIV status (serosorting) when deciding whether to share drug paraphernalia or to engage in condomless anal intercourse (CAS; Chen, Vallabhaneni, Raymond, & McFarland, 2012; Eaton, Kalichman, O'Connell, & Karchner, 2009; Philip, Yu, Donnell, Vittinghoff, & Buchbinder, 2010; Yang, Tobin, & Latkin, 2011; Zablotska et al., 2009), or using sexual positioning or withdrawal during CAS (Binson, Pollack, Blair, & Woods, 2010; Dubois-Arber, Jeannin, Lociciro, & Balthasar, 2012; Marks et al., 2010; McDaid & Hart, 2012; Parsons et al., 2005; Van de Ven et al., 2002). Biomedical strategies (i.e., preexposure and postexposure prophylaxis, and undetectable viral loads) to reduce HIV risk (Campbell, Herbst, Koppenhaver, & Smith, 2013) are not yet widely used among HIV-negative MSM (Krakower et al., 2012; Mutua et al., 2012), but their acceptability is increasing (Escudero et al., 2014; "
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    AIDS Care 04/2015; 27(8):1-8. DOI:10.1080/09540121.2015.1020280 · 1.60 Impact Factor
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    • "Three articles, from two trials, focused on heterosexual women’s experiences in serodiscordant relationships in African countries [37–39], with an additional article focusing on heterosexual women’s experiences in South Africa, Uganda and the US [40]. Two articles from one trial in Kenya explored acceptability and willingness amongst MSM [41, 42] while one article focused on MSM in the US [43]. The eighth article described the identification, development and implementation of procedures within the iPrEx study that intended to improve product use and self-report across all the trial sites [44]. "
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    ABSTRACT: Recent research has demonstrated how antiretrovirals (ARVs) could be effective in the prevention of sexually transmitted HIV. We review research on the acceptability of oral pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) for HIV prevention amongst potential users. We consider with whom, where and in what context this research has been conducted, how acceptability has been approached, and what research gaps remain. Findings from 33 studies show a lack of TasP research, PrEP studies which have focused largely on men who have sex with men (MSM) in a US context, and varied measures of acceptability. In order to identify when, where and for whom PrEP and TasP would be most appropriate and effective, research is needed in five areas: acceptability of TasP to people living with HIV; motivation for PrEP use and adherence; current perceptions and management of risk; the impact of broader social and structural factors; and consistent definition and operationalisation of acceptability which moves beyond adherence.
    AIDS and Behavior 07/2013; 18(2). DOI:10.1007/s10461-013-0560-7 · 3.49 Impact Factor
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