A Women-Focused PrEP Intervention

Completed · Phase 1

Conditions studied: Behavior and Behavior Mechanisms, Information Literacy

In brief

Many women at high risk for acquiring HIV infection are not aware of preexposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. The objective of this study is to evaluate the feasibility and acceptability of a theory-based intervention to promote PrEP uptake and adherence in a pilot trial among 80 women. The study will also measure intention to use PrEP and actual initiation of PrEP use. The investigators hypothesize that the intervention will be acceptable and feasible and that the intervention group will report higher levels of PrEP uptake, intention to use and adhere to PrEP, and other variables regarding PrEP uptake, comparing baseline, post-intervention and 3 month follow-up assessments.

Key facts

Study ID

NCT03699722

Run by

University of Pennsylvania

People needed

83

Starts

2018-11-03

Expected to finish

2019-11-10

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• female at birth and identify as female
• aged 18-55;
• report unprotected vaginal or anal sex with a male partner OR any injection drug use in the past 6 months;
• live or have sex in a high risk area or are recruited into the study by someone who lives or has sex in a high risk area;
• understand and read English;
• not known to be HIV-infected;
• are willing to consider a daily pill with low rates of mild side effects to prevent HIV;
• have access to a mobile phone.
• report at least one of the following as 'yes' or 'do not know': current male partner who injects drugs or has sex with men; current male partner who is HIV infected; current male partner who was incarcerated in the last 6 months OR report at least one of the following as 'yes': shared injection equipment in last 6 months; in methadone, buprenorphine or suboxone treatment program in past 6 months; exchange sex for money, drugs, other goods in last 6 months; powder cocaine, crack use, methamphetamines, or ecstasy >1x/week in last 6 months; Chlamydia, syphilis, gonorrhea diagnosed or newly diagnosed genital herpes in last 6 months; alcohol abuse in last 6 months (defined as a score of 2 or higher on the CAGE36); has 3 or more male partners.

You may not qualify if…

• currently using PrEP

Where it is running

• Anne Teitelman — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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