PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project

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Abstract

Introduction

HIV incidence remains high among African adolescent girls and young women (AGYW). The primary objective of this study is to assess pre‐exposure prophylaxis (PrEP) initiation, use, persistence and HIV acquisition among African AGYW offered PrEP in order to inform PrEP scale‐up.

Methods

POWER was a prospective implementation science evaluation of PrEP delivery for sexually active HIV‐negative AGYW ages 16–25 in family planning clinics in Kisumu, Kenya and youth and primary healthcare clinics in Cape Town and Johannesburg, South Africa. Follow‐up visits occurred at month 1 and quarterly for up to 36 months. PrEP users were defined based on the month 1 refill. PrEP persistence through month 6 was assessed using Kaplan–Meier survival analysis among AGYW with a month 1 visit, defining non‐persistence as an ≥15 day gap in PrEP availability for daily dosing. PrEP execution was evaluated in a subset with PrEP supply from the prior visit sufficient for daily dosing by measuring blood tenofovir diphosphate (TFV‐DP) levels.

Results

From June 2017 to September 2020, 2550 AGYW were enrolled (1000 in Kisumu, 787 in Cape Town and 763 in Johannesburg). Median age was 21 years, 66% had a sexual partner of unknown HIV status, and 29% had chlamydia and 10% gonorrhoea. Overall, 2397 (94%) initiated PrEP and 749 (31%) had a refill at 1 month. Of AGYW who could reach 6 months of post‐PrEP initiation follow‐up, 128/646 (20%) persisted with PrEP for 6 months and an additional 92/646 (14%) had a gap and restarted PrEP. TFV‐DP levels indicated that 47% (91/193) took an average of ≥4 doses/week. Sixteen HIV seroconversions were observed (incidence 2.2 per 100 person‐years, 95% CI 1.2, 3.5); 13 (81%) seroconverters either did not have PrEP dispensed in the study interval prior to seroconversion or TFV‐DP levels indicated <4 doses/week in the prior 6 weeks.

Conclusions

In this study of PrEP integration with primary care and reproductive health services for African AGYW, demand for PrEP was high. Although PrEP use decreased in the first months, an important fraction used PrEP through 6 months. Strategies are needed to simplify PrEP delivery, support adherence and offer long‐acting PrEP options to improve persistence and HIV protection.

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Most cited references 35

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Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Robert M Grant, Javier R Lama, Peter L Anderson … (2010)

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

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Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Jared Baeten, Deborah Donnell, Patrick Ndase … (2012)

New England Journal of Medicine, 367(5), 399-410

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Is Open Access

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

Sheena McCormack, David T. Dunn, Monica Desai … (2016)

Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. Interpretation In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. Funding MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.

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Author and article information

Contributors

Connie L. Celum: ccelum@uw.edu

Journal

Journal ID (nlm-ta): J Int AIDS Soc

Journal ID (iso-abbrev): J Int AIDS Soc

Journal ID (doi): 10.1002/(ISSN)1758-2652

Journal ID (publisher-id): JIA2

Title: Journal of the International AIDS Society

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Electronic): 1758-2652

Publication date (Electronic): 13 July 2022

Publication date Collection: July 2022

Volume: 25

Issue: 7 ( doiID: 10.1002/jia2.v25.7 )

Electronic Location Identifier: e25962

Affiliations

[ ¹ ] Department of Global Health University of Washington Seattle Washington USA

[ ² ] Department of Medicine University of Washington Seattle Washington USA

[ ³ ] Department of Epidemiology University of Washington Seattle Washington USA

[ ⁴ ] Department of Obstetrics and Gynecology University of Washington Seattle Washington USA

[ ⁵ ] Center for Microbiology Research Kenya Medical Research Institute Kisumu Kenya

[ ⁶ ] Desmond Tutu HIV Centre Cape Town South Africa

[ ⁷ ] Wits RHI University of the Witwatersrand Johannesburg South Africa

[ ⁸ ] Center for AIDS Prevention Studies, Department of Medicine University of California San Francisco San Francisco California USA

[ ⁹ ] Fred Hutchinson Cancer Center Seattle Washington USA

[ ¹⁰ ] University of Pittsburgh Pittsburgh Pennsylvania USA

[ ¹¹ ] University of Colorado‐Anschutz Medical Campus Aurora Colorado USA

[ ¹² ] Center for Global Health Massachusetts General Hospital Boston Massachusetts USA

[ ¹³ ] Department of Medicine Harvard Medical School Boston Massachusetts USA

[ ¹⁴ ] Gilead Sciences Foster City California USA

Author notes

[*] [* ] Corresponding author: Connie L. Celum, Department of Global Health, University of Washington, 325 Ninth Ave, HMC Box 359927, Seattle, WA 98104, USA. Tel: +1‐206‐520‐3824. ( ccelum@ 123456uw.edu )

Author information

Linda Gail Bekker https://orcid.org/0000-0002-0755-4386

Elzette Rousseau https://orcid.org/0000-0002-6487-6736

Ariane van der Straten https://orcid.org/0000-0001-8536-648X

Jessica E. Haberer https://orcid.org/0000-0001-5845-3190

Renee Heffron https://orcid.org/0000-0001-6039-0352

Jared M. Baeten https://orcid.org/0000-0001-8242-8438

Article

Publisher ID: JIA225962

DOI: 10.1002/jia2.25962

PMC ID: 9278271

PubMed ID: 35822945

SO-VID: 2b745d2f-d979-4b78-b77c-22391a7829a1

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

History

Date received : 14 September 2021

Date accepted : 23 June 2022

Page count

Figures: 2, Tables: 4, Pages: 9, Words: 6942

Custom metadata

source-schema-version-number 2.0

cover-date July 2022

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:13.07.2022

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: hiv,pre‐exposure prophylaxis,adherence,persistence,young women,africa

Data availability:

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: hiv, pre‐exposure prophylaxis, adherence, persistence, young women, africa

PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project

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Conclusions

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Most cited references 35

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

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