Adherence, Sexual Behavior and Sexually Transmitted Infections in a New Zealand Prospective PrEP Cohort: 12 Months Follow-up and Ethnic Disparities

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Abstract

Inequities in pre-exposure prophylaxis (PrEP) experiences will impede HIV epidemic elimination among gay and bisexual men (GBM). Ethnicity is a strong marker of inequity in the United States, but evidence from other countries is lacking. We investigated experiences on-PrEP to 12 months follow-up in a prospective cohort of 150 GBM in Auckland, New Zealand with an equity quota of 50% non-Europeans. Retention at 12 months was 85.9%, lower among Māori/Pacific (75.6%) than non-Māori/Pacific participants (90.1%). Missed pills increased over time and were higher among Māori/Pacific. PrEP breaks increased, by 12 months 35.7% of Māori/Pacific and 15.7% of non-Māori/Pacific participants had done so. Condomless receptive anal intercourse partners were stable over time. STIs were common but chlamydia declined; 12-month incidence was 8.7% for syphilis, 36.0% gonorrhoea, 46.0% chlamydia, 44.7% rectal STI, 64.0% any STI. Structural interventions and delivery innovations are needed to ensure ethnic minority GBM gain equal benefit from PrEP.

Clinical trial number ACTRN12616001387415.

Supplementary Information

The online version contains supplementary material available at 10.1007/s10461-022-03617-5.

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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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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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On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection.

Jean-Michel Molina, Catherine Capitant, Bruno Spire … (2015)

Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.

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Author and article information

Contributors

Peter J. W. Saxton:

ORCID: http://orcid.org/0000-0001-8696-0755

p.saxton@auckland.ac.nz

Journal

Journal ID (nlm-ta): AIDS Behav

Journal ID (iso-abbrev): AIDS Behav

Title: AIDS and Behavior

Publisher: Springer US (New York )

ISSN (Print): 1090-7165

ISSN (Electronic): 1573-3254

Publication date (Electronic): 15 February 2022

Publication date PMC-release: 15 February 2022

Pages: 1-15

Affiliations

[1 ]GRID grid.9654.e, ISNI 0000 0004 0372 3343, School of Population Health, , University of Auckland, ; 28 Park Ave, Auckland, 1023 New Zealand

[2 ]GRID grid.414057.3, ISNI 0000 0001 0042 379X, Auckland Sexual Health Regional Service, Auckland District Health Board, ; Auckland, New Zealand

[3 ]GRID grid.9654.e, ISNI 0000 0004 0372 3343, Department of Obstetrics and Gynaecology, , University of Auckland, ; Auckland, New Zealand

[4 ]Te Whāriki Takapou, Waikato, New Zealand

[5 ]New Zealand AIDS Foundation, Auckland, New Zealand

Author information

Peter J. W. Saxton http://orcid.org/0000-0001-8696-0755

Article

Publisher ID: 3617

DOI: 10.1007/s10461-022-03617-5

PMC ID: 8853116

PubMed ID: 35167038

SO-VID: 2ee1579d-ad38-47e1-bb03-f43a4e06855a

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date accepted : 5 February 2022

Funding

Funded by: new zealand aids foundation

Funded by: pharmac

Funded by: FundRef http://dx.doi.org/10.13039/100005564, gilead sciences;

Funded by: University of Auckland

Open Access :

Open Access funding enabled and organized by CAUL and its Member Institutions

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Adherence, Sexual Behavior and Sexually Transmitted Infections in a New Zealand Prospective PrEP Cohort: 12 Months Follow-up and Ethnic Disparities

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Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 76

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

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

On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection.

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