SCOPE: Strategies to Combine PrEP With Prevention Efforts (SCOPE)

Open Label Prospective Study of Strategies to Combine Pre-Exposure Prophylaxis (PrEP)With Prevention Efforts

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV
• Intervention / Treatment: Drug: Once daily Truvada®

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Family Health Options Kenya
  • Nairobi, Kenya
    • Sex Workers Outreach Programme (SWOP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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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Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Once daily Truvada®; One tablet of Truvada (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily

Drug: Once daily Truvada®; At the enrollment visit, participant's eligibility is assessed per protocol and she is provided with a 30 day supply of Truvada and instructed to take one tablet orally once daily with or without food. Each tablet contains 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF). Participants will receive Truvada at each clinic visit after it is confirmed that she is HIV negative. There will be a 1 month follow-up visit after enrollment. Thereafter, participants will have quarterly visits until April 2014.; Other Names: Truvada®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Adherence	Describe the patterns of adherence to a regimen of daily oral Truvada® among female sex workers currently or newly enrolled in established HIV prevention programs	11 months
PrEP Integration	Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers	11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess adherence	Describe self-reported and electronically-monitored patterns of adherence to a regimen of daily oral Truvada® among female sex workers currently or newly enrolled in established HIV prevention programs	11 months
drug level adherence	Assess the correlation between drug level adherence data and participant self-reported adherence data	11 months
risk-taking behavior	Assess the impact of PrEP on HIV risk-taking behavior	11 months
factors affecting Adherence	Identify factors associated with adherence to PrEP	11 months
Support of prEP Adherence	Assess impact of adherence support by peer educators on PrEP adherence	11 months
Contraceptive Use	Describe Contraceptive Use	11 months
Resistance among Seroconverters	Assess resistance to TFV or FTC among seroconverters	11 months
Birth Outcomes	Assess birth outcomes among women who choose to continue PrEP during pregnancy	11 months
Tenofovir Concentrations	9. Describe tenofovir concentrations among women who choose to continue PrEP during pregnancy	11 months

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Gilead Sciences; University of North Carolina, Chapel Hill; Family Health Options Kenya; Institute of Tropical Medicine; Sex Workers Outreach Programme
• Investigators: Principal Investigator: Jennifer Deese, MPH, FHI 360; Principal Investigator: Amy Corneli, Ph.D., FHI 360

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: HIV; PrEP; Female Sex Workers; Kenya
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: 391449

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No