The Acceptability and Feasibility of an HIV Preexposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men

Abstract

Background This study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for HIV pre-exposure prophylaxis (PrEP). Methods Project PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV-prevention intervention (3MV) alone, 3MV combined with PrEP (tenofovir/emtricitabine), and 3MV combined with placebo. Eligible participants were 18–22 year old HIV-uninfected men who reported unprotected anal intercourse (UAI) in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations, and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks. Results Sixty-eight youth (mean age = 19.97 years; 53% African-American, 40% Latino were enrolled; 58 were randomized. Self-reported medication adherence averaged 62% (range 43–83%) while rates of detectable tenofovir in plasma of participants in the FTC/TDF arm ranged from 63.2% (week 4) to 20% (week 24). There were 5 ≥ Grade 2 adverse events possibly/probably related to the study medication. Sexual risk behavior declined from baseline to week 24 in all study arms. Conclusions The feasibility of enrolling at risk youth, particularly YMSM of color, into Project PrEPare has been demonstrated. The acceptability of the group intervention along with counseling and testing was high. Self-reported medication adherence and corresponding plasma drug concentrations were low indicating the need for enhanced adherence counseling. Exploration of PrEP use among youth in non-randomized, open label trials is warranted.

The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development

“…Articles were excluded for not being a RCT or other suitable study, as specified in our inclusion criteria; not having the sufficient percentage of MSM in the study population; [137][138][139][140][141][142][143][144][145] not including a sufficient percentage of HIV-negative participants; [146][147][148][149][150][151][152][153][154][155][156] or not being an individually focused intervention, instead focusing on groups or structural factors. [157][158][159][160][161][162][163][164][165][166][167] Other reasons for exclusion, such as interventions not being brief, reporting a pilot trial, reporting non-HIV-specific data (e.g. if only alcohol-related outcomes were provided in a study assessing alcohol as well as HIV risk-related behaviours) or data were unobtainable despite our attempts to gain information from authors, were captured in our 'other' category.…”

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

“…MSM are considered by clinicians to be potential candidates for PrEP, 9 and studies have demonstrated that PrEP is an acceptable intervention to young MSM, 10,11 However, for PrEP to be an effective intervention, healthcare providers must be willing to prescribe this medication to youth. Potential providers of PrEP to adults have described a variety of concerns related to PrEP, including concerns about adherence, [12][13][14][15][16] development of viral resistance with incomplete adherence, 12,[14][15][16][17][18][19][20] high cost and insufficient coverage by insurance, 12,14,16,19,20 medication toxicity 12,14,17,18 and side effects, 16,17,19 efficacy outside of a clinical trial setting, 13,14,17,20 and risk compensation.…”

Pre-exposure prophylaxis for South African adolescents: What evidence?

“…ATN 082 enrolled 68 individuals (mean age 19.9 years) in a placebocontrolled study in which 58 individuals were randomised to a behavioural intervention alone or the behavioural intervention either with TDF/FTC or placebo. [29] Self-reported medication adherence averaged 62% (range 43 -83%), while rates of detectable plasma tenofovir ranged from 63.2% to 20% (weeks 4 -24). The most commonly reported reasons for missing doses included being away from home (60%), forgetting (50%) and being too busy (47%).…”

“…The most commonly reported reasons for missing doses included being away from home (60%), forgetting (50%) and being too busy (47%). [29] ATN 110 enrolled 200 MSM aged 18 -22 years who were offered the same behavioural intervention with oral PrEP but in an openlabel manner. PrEP was well tolerated with minimal side-effects.…”