Clinical trial NCT01832571: SCOPE: Strategies to Combine PrEP With Prevention Efforts
Official title: Open Label Prospective Study of Strategies to Combine Pre-Exposure Prophylaxis (PrEP)With Prevention Efforts
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV
Keywords: HIV
PrEP
Female Sex Workers
Kenya
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Family Health Options Kenya
name: Gilead Sciences
name: Institute of Tropical Medicine
name: Sex Workers Outreach Programme
name: University of North Carolina, Chapel Hill
First posted: 2013-04-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This pilot, open-label, prospective study will determine the feasibility of integrating pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers and if women who are enrolled in those programs will adhere to the daily PrEP regimen of Truvada®. This study will enroll 500 HIV antibody negative female sex workers in Eldoret and Nairobi, Kenya.

Detailed description: Participants will undergo the following procedures: blood draw for HIV (screening, enrollment, month 1, quarterly follow-up visits and final) and creatinine testing (screening, month 3 and final) and urine pregnancy test (at screening, enrollment and final). At screening, participants will have an HBV antigen test. Information on demographics, sexual behaviors, risk perceptions, partners' HIV status, medical history, PrEP and program acceptability, self-reported adherence to PrEP, alcohol and drug use, depression, social support, stigma, self-efficacy, gender-based violence, contraceptive use, adverse events, and symptoms of potential acute HIV infection will be collected during the study. Detailed information on Truvada for PrEP will be given to the participant and the the participant will be counseled on HIV-risk reduction (according to existing program) during the screening visit. Patient-centered and integrated counseling on HIV risk reduction and PrEP adherence will be conducted at enrollment and follow-up visits. Sexually transmitted infections (STI)will be assessed and treated during visits per local clinical procedures. If a pelvic exam is done per routine clinic procedures, a vaginal and/or endocervical swab will be collected and stored for future research related to HIV infection.

A cohort of 25 systematically-selected participants at each site will have three rounds of in-depth interviews (IDI) to explore the context surrounding many of the study's endpoints. The first IDI will be conducted at the month 1 visit after PrEP initiation. The second IDI will be conducted at the month 3 visit. The third IDI will be conducted at the final study visit.

An IDI will be conducted with all participants at each site who were assigned and willing to use the electronic pill monitoring device (n=25 per site). The purpose of the IDIs is to explore the reasons underlying PrEP use patterns (e.g. the number of times the pill bottle was opened over a specific period of time -- limited, intermittent, or high number of openings). Two rounds of IDIs will be conducted with these participants. The first IDI will be conducted at the month 3 visit and the second at the month 6 visit.

Exit interviews will be conducted with up to 30 participants at each site. Participants may be purposefully selected based on their drug level adherence data or electronic pill measurement data (e.g. low, intermittent, or high PrEP users) or based on other specific issues that emerged over the course of the study (e.g., limited partner support).

Two brief face-to-face (FTF) structured surveys will be administered to all HIV prevention program staff to assess the variables/domains related to the feasibility measures. The first survey will be administered around the initiation of the study and the second survey towards the end of the study. Two interviews will be conducted using a questionnaire with both open- and closed-ended questions, with all counselors and providers, such as nurses, medical officers, and doctors, to gather more in-depth data on the feasibility measures. The first interview will be conducted approximately one month after the first participant is screened and the second interview toward the end of the study.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Willing and able (i.e., successfully complete an open-ended comprehension assessment on key topics related to the study) to give written informed consent
* Expresses willingness at screening and enrollment to take PrEP daily
* Willing to provide contact information and be contacted by staff between visits (per participant-approved methods)
* Is sexually active, defined as having had at least one vaginal sex act in the last four weeks, and reports receiving money or goods in exchange for sex in the last 6 months as part of her source of income/livelihood
* Is HIV antibody negative on rapid test algorithm at the enrollment visit
* Does not have symptoms suggestive of acute HIV infection at the enrollment visit (i.e., fever (temperature above 38ºC), fatigue, sweating, night sweats, pain, rash, pharyngitis, headache, muscle and joint pain, adenopathy (cervical and inguinal), vomiting, diarrhea and coughing) combined with self-reported possibility of recent HIV exposure leading to clinical suspicion of acute HIV infection
* Has a negative urine pregnancy test at screening and enrollment
* Is not currently trying to become pregnant
* Is not breastfeeding
* Has a creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) at screening
* Is Hepatitis B virus antigen (HBV Ag) negative at screening
* Is in general good health and does not have a medical or social condition which may make study participation unsafe or complicate data interpretation in the opinion of the site investigator
* Is not participating in another PrEP program or PrEP research study
* Is not taking HIV post-exposure prophylaxis at enrollment

Exclusion Criteria:

Pregnant HIV antibody positive Using HIV post-exposure prophylaxis at enrollment

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Primary outcomes:
measure: Drug Adherence
timeFrame: 11 months
measure: PrEP Integration
timeFrame: 11 months
Secondary outcomes:
measure: Assess adherence
timeFrame: 11 months
measure: drug level adherence
timeFrame: 11 months
measure: risk-taking behavior
timeFrame: 11 months
measure: factors affecting Adherence
timeFrame: 11 months
measure: Support of prEP Adherence
timeFrame: 11 months
measure: Contraceptive Use
timeFrame: 11 months
measure: Resistance among Seroconverters
timeFrame: 11 months
measure: Birth Outcomes
timeFrame: 11 months
measure: Tenofovir Concentrations
timeFrame: 11 months
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Family Health Options Kenya
city: Nairobi
country: Kenya
facility: Sex Workers Outreach Programme (SWOP)
Study officials:
affiliation: FHI 360
name: Jennifer Deese, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Amy Corneli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: