A Women-Focused PrEP Intervention
A Women-Focused PrEP Intervention
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.
The HIV epidemic among women in the US is a major public health issue and many women at high
 risk for acquiring HIV infection are not aware of pre-exposure prophylaxis (PrEP), an
 efficacious, self-administered, woman-controlled, HIV prevention product. In 2014, the
 Centers for Disease Control and Prevention (CDC) and the American College of Obstetricians
 and Gynecologists (ACOG) issued guidelines for evaluating and prescribing PrEP for women at
 high risk for acquiring HIV. Yet, there are currently no interventions in the US to promote
 PrEP uptake among high risk women.

 The objective of this study is to evaluate an intervention to promote PrEP uptake in two
 large metropolitan areas with local HIV rates that greatly exceed the national average but
 with different PrEP public policy and access landscapes. The investigators hypothesize that a
 theory-based, contextually relevant behavioral intervention combined with linkage to health
 care and social services, with text message support for adherence, would be feasible and
 acceptable and would improve PrEP uptake among high risk women.

 Eligible women will be recruited primarily via face-to-face recruitment and respondent driven
 sampling. For respondent driven sampling, enrolled participants will be given three (3)
 coupons to be given to women in her social network who she thinks would be interested in
 joining the study. If the person referred attends a baseline visit, the referring participant
 will receive $10. Assessment of eligibility will be conducted by telephone or in-person.
 Participant initials and phone number will be recorded on the form. Eligible participants
 will be scheduled for a study visit at a day and time convenient for her. Study visits will
 be held at UPenn School of Nursing (Philadelphia) or the New York Blood Center Project
 Achieve office (NYC) or at a mutually agreeable location in the community that provides a
 private place for study procedures.

 For the randomized trial, the investigators will conduct a study among 80 women to evaluate
 the feasibility and acceptability of the intervention. Each of the two study sites will
 enroll forty (40) women; thirty (30) participants will receive the theory-based, contextually
 tailored education and activities intervention and ten (10) participants will be randomized
 to the information only control group.

 Prior to administering any study procedures women participants will participate in an
 informed consent process. During the informed consent process research staff will explained
 some participants will receive the education and activities intervention and some
 participants will receive information control group. After their questions are answered and
 participant signs the consent form, all participants will complete a computer-based baseline
 assessment and receive a rapid HIV test. All participants (control and intervention) will
 sign a release of information form authorizing the study team to contact the PrEP health care
 site for the minimal information needed to assess if PrEP was prescribed.

 Randomization will be performed centrally by the project statistician, and implemented using
 opaque sealed envelopes. Envelopes will be numbered and shipped to each study site. Balance
 between arms will be maintained by use of randomly permutated blocks with unequal block sizes
 of 4 and 8 (to allow for the 3:1 randomization ratio), and with stratification by site (2
 strata). At each site, a sealed envelope will be opened, in consecutive order, indicating
 study arm.

 Upon completing the computer-based survey, participants randomized to the education and
 activities intervention arm will receive an individual tailored in-person session, conducted
 by a trained counselor/navigator (CN). Participants will also be asked to design simple
 personalized text messages for asking about PrEP initiation and PrEP adherence reminders once
 starting PrEP. Finally, the CN will also coordinate with the participant the best day and
 time to schedule her four (4) follow-up phone calls. During the phone calls, the CN will
 reinforce skills for PrEP uptake, review the action plan regarding identified vulnerability
 factors that could interfere with PrEP uptake and reinforce strategies to access referrals.

 Participants randomized to the information only arm will meet with the counselor/navigator to
 review resources regarding PrEP and receive a list of providers/clinics prescribing PrEP.

 After the session, participants will complete a post-session computer-bases survey to assess
 social-cognitive variables targeted in the intervention. Participants will also complete a
 Participant's Brief Satisfaction Questionnaire to provide feedback on the session.

 All participants will be compensated $50.00 All participants enrolled will return to the
 study site for a three (3) month follow-up study visit to complete the computer-based survey
 and a questionnaire evaluating her experience navigating through the process to obtain
 provider appointment, medical assessment for PreP, prescription and taking PreP. Participants
 will be compensated $50.00 upon completing the three (3) month follow-up study visit.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  currently using PrEP