Dataset Information

High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.

ABSTRACT: Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ?80% adherence to daily tablet, 41% having perfect adherence; 83% had ?80% adherence to daily gel, 29% having perfect adherence; and 93% had ?80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ?80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.

SUBMITTER: Carballo-Dieguez A

PROVIDER: S-EPMC5531503 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.

Carballo-Diéguez Alex A Balán Ivan C IC Brown William W Giguere Rebecca R Dolezal Curtis C Leu Cheng-Shiun CS Marzinke Mark A MA Hendrix Craig W CW Piper Jeanna M JM Richardson Barbra A BA Grossman Cynthia C Johnson Sherri S Gomez Kailazarid K Horn Stephanie S Kunjara Na Ayudhya Ratiya Pamela RP Patterson Karen K Jacobson Cindy C Bekker Linda-Gail LG Chariyalertsak Suwat S Chitwarakorn Anupong A Gonzales Pedro P Holtz Timothy H TH Liu Albert A Mayer Kenneth H KH Zorrilla Carmen C Lama Javier J McGowan Ian I Cranston Ross D RD

PloS one 20170727 7

Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if particip ...[more]

PMID: 28750059

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Project description:PurposeDisparities persist in HIV infection among Black and Latino men who have sex with men (BLMSM) and Black and Latina transgender women (BLTW). Increasing uptake and subsequent consistent use of pre-exposure prophylaxis (PrEP), an effective biomedical strategy for preventing HIV acquisition, can dramatically reduce HIV incidence in these populations. The purpose of this study was to explore reasons for PrEP discontinuation among BLMSM and BLTW living in Los Angeles County to inform the development of support services for these populations to remain persistent with their PrEP regimen.MethodsIn-depth, semi-structured interviews were conducted with 15 BLMSM and 7 BLTW who reported either temporary or indefinite PrEP discontinuation. A thematic analysis approach was used to analyze qualitative data.ResultsFour themes emerged related to reasons for PrEP discontinuation, including: (1) lower perceived HIV risk related to changes in sexual behavior; (2) structural or logistical barriers (e.g., lapse or loss of health insurance, cost, difficulty navigating complex medical systems); (3) anticipated and experienced medication side effects, with a sub-theme of interactions between PrEP and feminizing hormone medications; and (4) challenges with medication adherence.ConclusionsPrEP is an important prevention tool for BLMSM and BLTW, particularly during periods of heightened HIV risk. However, both individual (e.g., inability to adhere to medication, changes in HIV sexual risk behaviors) and structural/logistical (e.g., loss of insurance, navigating complex medical systems) factors can cause temporary or indefinite PrEP discontinuation. Additional support services, beyond those offered by medical providers, are needed to help BLMSM and BLTW PrEP users overcome barriers to discontinuation and assist them to remain persistent with their PrEP regimen. We describe potential options for support services such as PrEP case management, expanded PrEP navigation services, or text messaging services.

Project description:INTRODUCTION:There is emerging data on HIV-1 incidence among MSM in sub-Saharan Africa (SSA), but no known estimate of HIV-1 incidence among transgender women (TGW) in the region has yet been reported. We assessed HIV-1 incidence and pre-exposure prophylaxis (PrEP) interest in men who have sex with men exclusively (MSME), men who have sex with men and women (MSMW) and TGW in coastal Kenya. METHODS:HIV-1-seronegative individuals who had participated in an HIV testing study in 2016 were traced and retested in 2017 according to Kenyan guidelines. All participants were assigned male sex at birth and had male sex partners; additional data on gender identity and sexual orientation were obtained. We assessed the factors associated with HIV-1 acquisition using Poisson regression and calculated HIV-1 incidence in MSME, MSMW and TGW. PrEP interest was assessed through focus group discussions to characterize subcategories' perceived PrEP needs. RESULTS:Of the 168 cohort participants, 42 were classified as MSME, 112 as MSMW and 14 as TGW. Overall, HIV-1 incidence was 5.1 (95% confidence interval (CI): 2.6 to 9.8) per 100 person-years (PY): 4.5 (95% CI: 1.1 to 17.8] per 100 PY among MSME, 3.4 (95% CI: 1.3 to 9.1) per 100 PY among MSMW and 20.6 (95% CI: 6.6 to 63.8] per 100 PY among TGW. HIV-1 acquisition was associated with exclusive receptive anal intercourse (aIRR 13.0, 95% CI 1.9 to 88.6), history of an STI in preceding six months (aIRR 10.3, 95% CI 2.2 to 49.4) and separated/divorced marital status (aIRR 8.2 (95%: 1.1 to 62.2). Almost all (98.8%) participants were interested in initiating PrEP. MSME and TGW felt that PrEP would lead to increases in condomless anal or group sex. CONCLUSIONS:TGW had a very high HIV-1 incidence compared with MSME and MSMW. Subcategories of MSM anticipated different PrEP needs and post-PrEP risk behaviour. Further studies should assess if TGW may have been wrongly categorized as MSM in other HIV-1 incidence studies in the region.

Dataset Information

High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.

Publications

High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.

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