Correction:Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project PRELUDE

ANRS-IPERGAY was a community-based randomized trial investigating the efficacy of sexual activity-based HIV pre-exposure prophylaxis (PrEP) in a population of males and transgender females who had sex with men and were at high risk of HIV infection. We qualitatively analyzed the support provided to participants by community-based health workers (CBHW) throughout the trial's double-blind and open-label extension phases. In particular, we showed that the relationship between participants and CBHW strongly influenced self-managed pill intake. The delicate construction of this relationship, balanced between trust and dependence, played an important role in PrEP adherence. CBHW had to deal with various issues surrounding participants' feelings of empowerment regarding their role in the trial, as well as related tensions between various logics and rationalities. They were essential to participants' continued involvement.

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Determinants of High-Risk Sexual Behavior during Post-Exposure Prophylaxis to Prevent HIV Infection

AIDS and Behavior ◽

10.1007/s10461-007-9286-8 ◽

2007 ◽

Vol 12 (6) ◽

pp. 852-859 ◽

Cited By ~ 12

Author(s):

Sarit A. Golub ◽

Lisa Rosenthal ◽

Daniel E. Cohen ◽

Kenneth H. Mayer

Keyword(s):

Sexual Behavior ◽

High Risk ◽

Hiv Infection ◽

Post Exposure Prophylaxis ◽

Post Exposure ◽

High Risk Sexual Behavior ◽

Exposure Prophylaxis ◽

Risk Sexual Behavior

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High pre-exposure prophylaxis uptake and early adherence among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil demonstration project

Journal of the International AIDS Society ◽

10.7448/ias.20.1.21472 ◽

2017 ◽

Vol 20 (1) ◽

pp. 21472 ◽

Cited By ~ 49

Author(s):

Brenda Hoagland ◽

Ronaldo I. Moreira ◽

Raquel B. De Boni ◽

Esper G. Kallas ◽

José Valdez Madruga ◽

...

Keyword(s):

At Risk ◽

Hiv Infection ◽

Transgender Women ◽

Demonstration Project ◽

Sex With Men ◽

Exposure Prophylaxis

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Pre-Exposure Prophylaxis for the Prevention of HIV Infection in High Risk Populations: A Meta-Analysis of Randomized Controlled Trials

PLoS ONE ◽

10.1371/journal.pone.0087674 ◽

2014 ◽

Vol 9 (2) ◽

pp. e87674 ◽

Cited By ~ 31

Author(s):

Junjun Jiang ◽

Xiaoyi Yang ◽

Li Ye ◽

Bo Zhou ◽

Chuanyi Ning ◽

...

Keyword(s):

High Risk ◽

Hiv Infection ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

High Risk Populations ◽

Exposure Prophylaxis ◽

Prevention Of Hiv

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Uptake, retention, and outcomes in a demonstration project of pre-exposure prophylaxis among female sex workers in public health centers in Senegal

International Journal of STD & AIDS ◽

10.1177/0956462420943704 ◽

2020 ◽

Vol 31 (11) ◽

pp. 1063-1072

Author(s):

Moussa Sarr ◽

Daouda Gueye ◽

Aminata Mboup ◽

Ousmane Diouf ◽

Mame D Bousso Bao ◽

...

Keyword(s):

Sex Workers ◽

Female Sex Workers ◽

Retention In Care ◽

Older Age ◽

Demonstration Project ◽

Retention Rates ◽

Open Label ◽

Female Sex ◽

Exposure Prophylaxis

The Senegal pre-exposure prophylaxis (PrEP) Demonstration Project was an open-label cohort study assessing the delivery of daily oral PrEP to HIV-negative female sex workers (FSWs) in four Ministry of Health (MoH)-run clinics in Dakar, Senegal. We assessed uptake, retention in care, and adherence over up to 12 months of follow-up as well as HIV infection rates. Between July and November 2015, 350 individuals were approached and 324 (92.6%) were preliminarily eligible. Uptake was high, with 82.4% of eligible participants choosing to enroll and take PrEP. The mean age of those enrolled was 37.7 years (SD = 8.7), and approximately half had not attended school (41.2%). Among the 267 participants who were prescribed PrEP, 79.9 and 73.4% were retained in PrEP care at 6 and 12 months, respectively. Older age among FSWs was found to be the only significant predictor of lower discontinuation. We did not find significant differences in retention by site, education, condom use, or HIV risk perception. There were no new HIV infections at follow-up. Our results showed evidence of high interest in PrEP and very good PrEP retention rates among FSWs at 12-month follow-up when offered in MoH-run clinics, with older age as the only significant predictor of higher PrEP retention. This highlights the role that these clinics can play in expanding PrEP access nationwide.

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Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa

Gates Open Research ◽

10.12688/gatesopenres.12752.1 ◽

2017 ◽

Vol 1 ◽

pp. 3 ◽

Cited By ~ 33

Author(s):

Renee Heffron ◽

Kenneth Ngure ◽

Josephine Odoyo ◽

Nulu Bulya ◽

Edna Tindimwebwa ◽

...

Keyword(s):

Hiv Infections ◽

Hiv Treatment ◽

Demonstration Project ◽

Open Label ◽

Serodiscordant Couples ◽

Treatment Services ◽

Hiv Serodiscordant Couples ◽

Exposure Prophylaxis ◽

Living With Hiv ◽

Hiv Negative

Introduction: Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk, such as individuals with a partner living with HIV. Demonstration projects of PrEP have been conducted in diverse settings worldwide to illustrate practical examples of how PrEP can be delivered. Methods: We evaluated delivery of PrEP for HIV-negative partners within heterosexual HIV serodiscordant couples in an open-label demonstration project in East Africa. The delivery model integrated PrEP into HIV treatment services, prioritizing PrEP for HIV-negative partners within serodiscordant couples prior to and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART). We measured adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial. Results: We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP. Ninety-seven percent (97%) of HIV-negative partners initiated PrEP, and when PrEP was dispensed, objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected. A total of 4 incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, p<0.0001) in HIV incidence, relative to estimated HIV incidence for the population in the absence of PrEP integrated into HIV treatment services. Conclusions: PrEP uptake and adherence were high and incident HIV was rare in this PrEP demonstration project for African HIV-negative individuals whose partners were known to be living with HIV. Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation.

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NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand

BMJ Open ◽

10.1136/bmjopen-2018-026363 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026363 ◽

Cited By ~ 2

Author(s):

Sunita Azariah ◽

Peter Saxton ◽

Richard Franklin ◽

Rose Forster ◽

Suzanne Werder ◽

...

Keyword(s):

New Zealand ◽

Sexual Health ◽

Gay And Bisexual Men ◽

Demonstration Project ◽

Bisexual Men ◽

Publicly Funded ◽

Open Label ◽

Behavioural Effects ◽

And Bisexual ◽

Exposure Prophylaxis

IntroductionNew Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this.Methods and analysisNZPrEP (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 disseminationThe 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 numberACTRN12616001387415; Pre-results.

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