Dataset Information

Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India.

ABSTRACT:

Background

HIV prevalence among female sex workers (FSWs) in India remains well above the national average. Pre-exposure prophylaxis (PrEP), a new HIV prevention technology, may help to reduce HIV incidence, but there is a dearth of research that can inform the potential scale-up of PrEP in India. In partnership with Ashodaya Samithi, a local sex worker collective, we conducted a feasibility study to assess acceptance of a planned PrEP demonstration project, willingness to use PrEP, and recommendations for project roll-out among FSWs in southern Karnataka.

Methods

From January-April 2015, 6 focus group discussions, 47 in-depth interviews, and 427 interviewer-administered questionnaires were completed by female sex workers. All participants were 18 years of age or older and practiced sex work. Qualitative data were coded for key themes and emergent categories. Univariate descriptive analysis was employed to summarise the quantitative data.

Results

Qualitative. PrEP was described as an exciting new prevention technology that places control in the hands of FSWs and provides a "double safety" in combination with condom use. Participants expressed agreement that women who may experience more HIV risk in their occupational environments should be prioritized for enrollment into a demonstration project. Quantitative. 406 participants (95%) expressed interest in PrEP. Participants prioritized the inclusion of FSWs under the age of 25 (79%), those who do not use condoms when clients offer more money (58%), who do not consistently use condoms with regular partners (57%), who drink alcohol regularly (49%), and who do not use condoms consistently with clients (48%).

Discussion

This feasibility study indicated strong interest in PrEP and a desire to move forward with the demonstration project. Participants expressed their responses in terms of public health discourses surrounding risk, pointing to the importance of situating PrEP scale up within the trusted spaces of community-based organizations as a means of supporting PrEP uptake and adherence.

SUBMITTER: Reza-Paul S

PROVIDER: S-EPMC5120793 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India.

Reza-Paul Sushena S Lazarus Lisa L Doshi Monika M Hafeez Ur Rahman Syed S Ramaiah Manjula M Maiya Raviprakash R Ms Venugopal V Venukumar K T KT Sundararaman Sundar S Becker Marissa M Moses Stephen S Lorway Robert R

PloS one 20161123 11

<h4>Background</h4>HIV prevalence among female sex workers (FSWs) in India remains well above the national average. Pre-exposure prophylaxis (PrEP), a new HIV prevention technology, may help to reduce HIV incidence, but there is a dearth of research that can inform the potential scale-up of PrEP in India. In partnership with Ashodaya Samithi, a local sex worker collective, we conducted a feasibility study to assess acceptance of a planned PrEP demonstration project, willingness to use PrEP, and ...[more]

PMID: 27880833

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Project description:BackgroundOperational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa.Methods and findingsThe TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention.ConclusionsPrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa.

Project description:ObjectivesModalities of pre-exposure prophylaxis (PrEP) for HIV prevention offer options to women at high risk including female sex workers (FSW). This study aimed to explore FSW's acceptability and preferences for oral pills, long-acting (LA) injectable and vaginal ring PrEP.DesignSequential, explanatory, mixed methods.SettingIringa, Tanzania.ParticipantsFSW aged above 18 were recruited from sex work venues using time-location sampling (n=496); HIV-uninfected (n=293) were included in this analysis. Subsequently, survey participants were recruited for in-depth interviews (n=10) and two focus group discussions (n=20).Primary outcome measures(1) Acceptability of PrEP (Do you personally think it would be worth it to you to take ART if it could prevent HIV?: yes/no) and (2) preference for LA injectable versus oral pills (If you personally were going to take ART to prevent HIV infection, would you prefer to take it in the form of a daily pill or an injection once every 3 months? Injection/pill).ResultsParticipants were (92%) unaware of PrEP but 58% thought it would be worth it to personally take PrEP. Acceptability of PrEP was significantly associated with higher social cohesion (aOR 2.12; 95% CI 1.29 to 3.50) and STI symptoms in the past 6 months (aOR 2.52; 95% CI 1.38 to 4.62). Most (88%) preferred LA vs oral PrEP. Qualitative findings revealed generally positive reactions to all types of PrEP, and they were viewed as a welcome backup to condoms. Participants had concerns about pills (burden of daily use, stigma from clients), and the vaginal ring (fear of client noticing and becoming suspicious, fear of infertility) and overall preferred LA-PrEP (less frequent use, easy to hide, belief in higher efficacy).ConclusionsOffering multiple formulations of PrEP within the context of community-driven HIV prevention interventions among FSW may facilitate increased uptake and adherence. LA injectable PrEP may be a particularly preferred formulation among FSW.Trial registration numberNCT02281578.

Project description:OBJECTIVES:Female sex workers (FSWs) play a key role in HIV transmission in West Africa, while they have limited access to antiretroviral therapy (ART). In line with UNAIDS recommendations extending ART to all HIV-infected individuals, we conducted this demonstration project on immediate treatment as prevention (TasP) among FSWs in Cotonou, Benin. We report data on treatment response and its relation to adherence, as well as on ART-resistant genotypes. METHODS:Complete follow-up varied between 12 and 24 months. At each three-monthly visit, a questionnaire was administered, clinical examinations were carried out and blood samples collected. Adherence to treatment was estimated by self-report. Viral RNA was genotyped at baseline and final visits for drug resistance. Generalized estimating equations for repeated measures with a log-binomial link were used to analyze time trends and the association between adherence and virological response to treatment. RESULTS:One-hundred-seven HIV-positive and ART-naive FSWs were enrolled; 59.8% remained in the cohort till study completion and 62.6% had a final visit. Viral load<1000 (below quantification limit [<50]) was attained in 73.1% (64.6%) of participants at month-6, 84.8% (71.2%) at month-12, and 80.9% (65.1%) at the final visit. The proportion of women with suppressed (below quantification limit) viral load increased with increasing self-reported adherence (p = 0.06 (0.003), tests for trend). The proportion of participants with CD4≤500 also decreased drastically throughout follow-up (p < .0001). Twelve participants exhibited ART-resistant genotypes at baseline, but only two at their final visit. CONCLUSION:Our findings indicate that TasP is widely accepted among FSWs in Cotonou and could be implemented with relative success. However, due to mobility in this population, follow-up was sub-optimal, suggesting that large geographical coverage of FSW-friendly clinics is needed for sustained treatment implementation. We also fell short of the UNAIDS objective of 90% viral suppression among treated patients, underlining the need for better adherence support programs.

Project description:BACKGROUND:Measuring adherence to PrEP (pre-exposure prophylaxis) remains challenging. Biological adherence measurements are reported to be more accurate than self-reports and pill counts but can be expensive and not suitable on a daily basis in resource-limited countries. Using data from a demonstration project on PrEP among female sex workers in Benin, we aimed to measure adherence to PrEP and compare self-report and pill count adherence to tenofovir (TFV) disoproxil fumarate (TDF) concentration in plasma to determine if these 2 measures are reliable and correlate well with biological adherence measurements. METHODS:Plasma TFV concentrations were analyzed in samples collected at day 14 follow-up visit and months 6, 12, 18, and 24 (or at last visit when follow-up was shorter). Self-reported adherence was captured at day 14 follow-up visit and then quarterly by asking participants to report the number of missed pills within the last week. For pill count, medications were refilled monthly and participants were asked to bring in their medication bottles at each follow-up visit. Using generalized estimating equations adherence measured by self-report and pill count was compared to plasma drug concentrations. RESULTS:Of 255 participants, 47.1% completed follow-up. Weighted optimal adherence combining data from all visits was 26.8% for TFV concentration, 56.0% by self-report and 18.9% by pill count. Adherence measured by both TFV concentrations and self-report decreased over time (P?=?.009 and P?=?.019, respectively), while the decreasing trend in adherence by pill count was not significant (P?=?.087). The decrease in adherence was greater using TFV concentrations than the other 2 adherence measures. CONCLUSION:With high levels of misreporting of adherence using self-report and pill count, the objective biomedical assessment of adherence via laboratory testing is optimal and more accurately reflects PrEP uptake and persistence. Alternative inexpensive and accurate approaches to monitor PrEP adherence should be investigated.

Project description:INTRODUCTION:New Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this. METHODS AND ANALYSIS:NZPrEP (A demonstration project of HIV preexposure prophylaxis in Aotearoa New Zealand) is an open-label, single-arm treatment evaluation study to investigate feasibility, retention, adherence, and clinical and behavioural outcomes of HIV pre-exposure prophylaxis (PrEP) provision to gay and bisexual men (GBM) in a publicly funded secondary sexual health service in Auckland, New Zealand. The sample size is 150 GBM. Inclusion criteria were specific behavioural risk factors indicating an increased risk of HIV infection. Exclusion criteria were hepatitis B infection, any medical contraindications to prescribing tenofovir/emtricitabine or factors limiting ability to adhere to the study protocol. Eligible participants will be screened for HIV and other sexually transmissible infections (STIs) and for any medical contraindications to PrEP, and enrolled for a maximum follow-up period of 96 weeks. They will be required to attend for 3-monthly testing for HIV and STIs and monitoring for renal and liver toxicity. Participants will also be required to complete an online behavioural survey after each study visit. The outcomes of interest are feasibility of PrEP provision in a sexual health clinic setting, PrEP acceptability, and adverse medical and behavioural effects of PrEP. The study sample is limited to 150 participants due to funding and service constraints. Statistical analysis of all primary and secondary outcomes will be performed using Stata V.14 at the University of Auckland. Results for primary and secondary endpoints will be reported after the conclusion of the study in March 2019. ETHICS AND DISSEMINATION:The study was approved by the Health and Disability Ethics Committee on 15 September 2016 (16/NTA/112). Key findings will be submitted to peer-reviewed journals. A summary report will be circulated to the study and community stakeholders, and to the Auckland District Health Board, Ministry of Health and Pharmac. TRIAL REGISTRATION NUMBER:ACTRN12616001387415; Pre-results.

Dataset Information

Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India.

Background

Methods

Results

Discussion

Publications

Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India.

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