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Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently?

ABSTRACT: BACKGROUND/SETTING:Randomized controlled trials (RCTs) of HIV biomedical prevention interventions often enroll participants with varying levels of HIV exposure, including people never exposed to HIV. We assessed whether enrolling larger proportion of participants with consistently high exposure to HIV, such as female sex workers (FSWs), might reduce trial duration and improve the accuracy of product efficacy estimates in future HIV prevention trials. METHODS:We used an individual-based stochastic model to simulate event-driven RCTs of an HIV prevention intervention providing 80% reduction in susceptibility per act under different proportions of FSW enrolled. A 5% annual dropout rate was assumed for both FSW and non-FSW in our main scenario, but rates of up to 50% for FSW were also explored. RESULTS:Enrolling 20% and 50% FSW reduced the median-simulated trial duration from 30 months with 0% FSW enrolled to 22 months and 17 months, respectively. Estimated efficacy increased from 71% for RCTs without FSW to 74% and 76% for RCTs with 20% and 50% FSW enrolled, respectively. Increasing the FSW dropout rate to 50% increased the duration of RCTs by 1-2 months on average and preserved the gain in estimated efficacy. CONCLUSIONS:Despite the potential logistical challenges of recruiting and retaining FSW, trialists should revisit the idea of enrolling FSW in settings where HIV incidence among FSW is higher than among non-FSW. Our analysis suggests that enrolling FSW would increase HIV incidence, reduce trial duration, and improve efficacy estimates, even if the annual dropout rate among FSW participants is high.

SUBMITTER: Wood D

PROVIDER: S-EPMC5825250 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently?

Wood Daniel D Lancaster Kathryn E KE Boily Marie-Claude MC Powers Kimberly A KA Donnell Deborah D Cohen Myron S MS Dimitrov Dobromir T DT

Journal of acquired immune deficiency syndromes (1999) 20180401 4

<h4>Background/setting</h4>Randomized controlled trials (RCTs) of HIV biomedical prevention interventions often enroll participants with varying levels of HIV exposure, including people never exposed to HIV. We assessed whether enrolling larger proportion of participants with consistently high exposure to HIV, such as female sex workers (FSWs), might reduce trial duration and improve the accuracy of product efficacy estimates in future HIV prevention trials.<h4>Methods</h4>We used an individual- ...[more]

PMID: 29206720

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Project description:BackgroundIn the context of the mostly generalized HIV epidemic in Côte d'Ivoire, key populations bear a higher burden of HIV than that borne by the general reproductive-aged population. Mathematical models have demonstrated the significant potential impact and cost-effectiveness of improving the coverage of HIV prevention and treatment services for key populations in Côte d'Ivoire. However, in 2019, coverage of these services remained limited by multiple intersecting stigmas affecting key populations, necessitating the study of innovative implementation strategies to better meet the needs of those most marginalized. Here, we leverage programmatic data to compare the effectiveness of the enhanced and traditional peer outreach approaches in reaching and providing community HIV testing to female sex workers not readily engaged in HIV prevention and treatment services in Côte d'Ivoire.ObjectiveThe aim of this study was to describe the characteristics of female sex workers reached by the LINKAGES project in Côte d'Ivoire with enhanced peer outreach and traditional peer outreach and to compare HIV-related outcomes between the women reached by both strategies.MethodsDeidentified routine programmatic data collected as part of LINKAGES Côte d'Ivoire between October 2017 and April 2018 were used in these analyses. Demographic characteristics and HIV indicators including HIV testing history, HIV case-finding, linkage to HIV treatment, and treatment initiation were assessed using descriptive statistics. Differences in these indicators were compared by outreach strategy using Pearson chi-square tests.ResultsThere were 9761 women reached with enhanced peer outreach and routine peer outreach included in these analyses. The overall case-finding rate in the sample was 7.8% (698/8851). Compared with women reached by routine outreach, those reached by enhanced peer outreach were more likely to have previously been tested for HIV (enhanced: 1695/2509, 67.6%; routine: 4302/7252, 60.0%; χ21=43.8; P=.001). The enhanced peer outreach approach was associated with a higher HIV case-finding rate (enhanced: 269/2507 10.7%; routine: 429/6344, 6.8%; χ21=32.3; P=.001), higher proportion of linkage to treatment (enhanced: 258/269, 95.9%; routine: 306/429, 71.3%; χ21=64.4; P=.001), and higher proportion of treatment initiation (enhanced: 212/269, 78.8%; routine: 315/429, 73.3%; χ21=2.6; P=.11). Women reached by both approaches were categorized as high risk for HIV-related behaviors such as condomless sex and number of sex acts in the previous week.ConclusionsThese analyses suggest that the novel peer-referral strategy, the enhanced peer outreach approach, was effective in reaching female sex workeres in Côte d'Ivoire with demonstrated acquisition risks for HIV and who had not been effectively engaged by routine outreach approaches. Scaling up novel strategies such as enhanced peer outreach in the context of differentiated service models may be needed to optimize HIV prevention and treatment outcomes for key populations in Côte d'Ivoire.

Project description:Highly Exposed-Seronegatives (HESN) individuals do not contract HIV-1 infection despite long-term exposure; few comprehensive studies examining behavior, mucosal tissue, and peripheral immune parameters in sexually-exposed HESN have been completed. To this end, we assessed rate of condomless vaginal sex, the immune activation status (peripheral blood) and gene expression (ectocervical biopsies) in female cohort of high-risk female sex workers [FSW] (n=50) and non-sex worker women [CG] (n=32) in San Juan, Puerto Rico, USA. Of the 50 FSWs examined only 5 had detectable anti-HIV responses by either HIV gag-specific CD8+ T-Cell responses or mucosal anti-HIV envelope IgG/IgA. FSW had a uniform lower CD38 expression on circulating CD4+ or CD8+ T-Cells (both: p<0.0001:Wilcoxon Rank Sum). Cervical tissue from FSWs had greater levels of CD4+ T-Cell (p=0.040), CD123+ plasmacytoid Dendritic Cells (p=0.013) and CD68+ macrophage infiltrates (p=0.038). Cervical gene expression by RNA microarray indicated that FSW had a gene signature characterized by lower expression of genes associated with leukocyte homing and chemotaxis; partial interferon regulated gene signature; and lower gene expression of genes required for HIV infection such as CD4 and NUP153 indicating a lower mucosal immune activation state and reduced susceptibility to HIV-1 infection within mucosal tissue. Notably, Interferon (IFN)-ε expression was higher in FSW than CG women, as detected by RNA (microarray) and protein (IHC) expression in cervical epithelium. The observed levels of IFNε were associated with the reported frequency of unprotected intercourse. Finally, IFNε was induced by treatment of the ECT1 cell line with seminal fluid, suggesting that semen exposure may contribute to long-term protection. Decreased levels of immune activation and gene expression required for HIV infection along with semen-induced epithelial Interferon ε production within the reproductive tract of FSWs highlight distinct host intrinsic resistance mechanisms that may contribute to long-term HIV seronegative status in spite of high-risk condomless sex.

Project description:IntroductionHIV prevention cascades have emerged as a programme management and monitoring tool that outlines the sequential steps of an HIV prevention programme. We describe the application of an HIV combination prevention programme cascade framework to monitor and improve HIV prevention interventions for female sex workers (FSWs) in Kenya.MethodsTwo data sources were analysed: (1) annual programme outcome surveys conducted using a polling booth survey methodology in 2017 among 4393 FSWs, and (2) routine programme monitoring data collected by (a) 92 implementing partners between July 2017 and June 2018, and (b) Learning Site in Mombasa (2014 to 2015) and Nairobi (2013). We present national, sub-national and implementing partner level cascades.ResultsAt the national level, the population size estimates for FSW were 133,675 while the programme coverage targets were 174,073. Programme targets as denominator, during the period 2017 to 2018, 156,220 (90%) FSWs received peer education and contact, 148,713 (85%) received condoms and 83,053 (48%) received condoms as per their estimated need. At the outcome level, 92% of FSWs used condoms at the last sex with their client but 73% reported consistent condom use. Although 96% of FSWs had ever tested for HIV, 85% had tested in the last three months. Seventy-nine per cent of the HIV-positive FSWs were enrolled in HIV care, 73% were currently enrolled on antiretroviral therapy (ART) and 52% had attended an ART clinic in the last month. In the last six months, 48% of the FSWs had experienced police violence but 24% received violence support. National and sub-national level cascades showed proportions of FSWs lost at each step of programme implementation and variability in programme achievement. Hotspot and sub-population level cascades, presented as examples, demonstrate development and use of these cascades at the implementation level.ConclusionsHIV prevention programme cascades, drawing on multiple data sources to provide an understanding of gaps in programme outputs and outcomes, can provide powerful information for monitoring and improving HIV prevention programmes for FSWs at all levels of implementation and decision-making. Complexity of prevention programmes and the paucity of consistent data can pose a challenge to development of these cascades.

Project description:BACKGROUND: Female Sex workers (FSW) are important in driving HIV transmission in West Africa. The Yerelon clinic in Burkina Faso has provided combined preventative and therapeutic services, including anti-retroviral therapy (ART), for FSWs since 1998, with evidence suggesting it has decreased HIV prevalence and incidence in this group. No data exists on the costs of such a combined prevention and treatment intervention for FSW. This study aims to determine the mean cost of service provision per patient year for FSWs attending the Yerelon clinic, and identifies differences in costs between patient groups. METHODS: Field-based retrospective cost analyses were undertaken using top-down and bottom-up costing approaches for 2010. Expenditure and service utilisation data was collated from primary sources. Patients were divided into groups according to full-time or occasional sex-work, HIV status and ART duration. Patient specific service use data was extracted. Costs were converted to 2012 US$. Sensitivity analyses considered removal of all research costs, different discount rates and use of different ART treatment regimens and follow-up schedules. RESULTS: Using the top-down costing approach, the mean annual cost of service provision for FSWs on or off ART was US$1098 and US$882, respectively. The cost for FSWs on ART reduced by 29%, to US$781, if all research-related costs were removed and national ART monitoring guidelines were followed. The bottom-up patient-level costing showed the cost of the service varied greatly across patient groups (US$505-US$1117), primarily due to large differences in the costs of different ART regimens. HIV-negative women had the lowest annual cost at US$505. CONCLUSION: Whilst FSWs may require specialised services to optimise their care and hence, the public health benefits, our study shows that the cost of ART provision within a combined prevention and treatment intervention setting is comparable to providing ART to other population groups in Africa.

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Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently?

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Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently?

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