HPTN 073
Status:Completed
Phase:Demo Project, Open Label
Principal Investigator(s):Steven Shoptaw, PhD; Manya Magnus, PhD, MPH; Lisa Hightow-Weidman
Objective:Designed to assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM). A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. The study will recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will include those aged 18 and over with an effort to recruit an equal number of BMSM under age 25 and over age 25 with a total of 225 participants (75 per site).
*Results presented at the AIDS 2016 conference in 2016 demonstrated that PrEP was accepted by 178 (79 percent) study participants. Among those continuing PrEP at week 26, 62 percent self-reported high adherence. Drug concentrations consistent with taking pills at least four times a week were also observed in approximately the same proportion of participants. The protocol chair, Darrell P. Wheeler, Ph.D., M.P.H, stated, “The new report from HPTN 073 supports the primary research finding of high acceptability and uptake of oral PrEP among BMSM when combined with coordinated counseling,”*
Prevention Option(s):PrEP
Study Design:
Arms and Assigned Interventions
DescriptionAll participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.
Mode of Delivery
ARMs
Official Code:
NCT01808352
Trial Sponsors:
HIV Prevention Trials Network; NIAID/NIH
Start Date
End Date
August 31, 2013
September 1, 2015
Enrollment:225
Age range:
18 Years ↔
any
Population:Gay and Bisexual Men Who Have Sex with Men