SCOPE: Strategies to Combine PrEP With Prevention Efforts

This study has been withdrawn prior to enrollment.
(Study is closed early due to withdrawal of funding. No study procedures were implemented.)
Sponsor:
Collaborators:
Family Health Options Kenya
Gilead Sciences
Institute of Tropical medicine
Sex Workers Outreach Programme
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01832571
First received: April 3, 2013
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
HIV
Drug: Once daily Truvada®

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open Label Prospective Study of Strategies to Combine Pre-Exposure Prophylaxis (PrEP)With Prevention Efforts

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Drug Adherence [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
    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

  • PrEP Integration [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers


Secondary Outcome Measures:
  • Assess adherence [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    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

  • drug level adherence [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess the correlation between drug level adherence data and participant self-reported adherence data

  • risk-taking behavior [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess the impact of PrEP on HIV risk-taking behavior

  • factors affecting Adherence [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Identify factors associated with adherence to PrEP

  • Support of prEP Adherence [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess impact of adherence support by peer educators on PrEP adherence

  • Contraceptive Use [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Describe Contraceptive Use

  • Resistance among Seroconverters [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess resistance to TFV or FTC among seroconverters

  • Birth Outcomes [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    Assess birth outcomes among women who choose to continue PrEP during pregnancy

  • Tenofovir Concentrations [ Time Frame: 11 months ] [ Designated as safety issue: No ]
    9. Describe tenofovir concentrations among women who choose to continue PrEP during pregnancy


Enrollment: 0
Study Start Date: June 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832571

Locations
Kenya
Family Health Options Kenya
Eldoret, Kenya
Sex Workers Outreach Programme (SWOP)
Nairobi, Kenya
Sponsors and Collaborators
FHI 360
Family Health Options Kenya
Gilead Sciences
Institute of Tropical medicine
Sex Workers Outreach Programme
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jennifer Deese, MPH FHI 360
Principal Investigator: Amy Corneli, Ph.D. FHI 360
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01832571     History of Changes
Other Study ID Numbers: 391449
Study First Received: April 3, 2013
Last Updated: July 11, 2013
Health Authority: Kenya: Pharmacy and Poisons Board
Kenya: Medical Research Institute

Keywords provided by FHI 360:
HIV
PrEP
Female Sex Workers
Kenya

Additional relevant MeSH terms:
Tenofovir disoproxil
Tenofovir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 15, 2014