Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03699722 |
| Other study ID # |
1R34MH108437-01A1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2018 |
| Est. completion date |
November 10, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
