HIVSCOPENCT01832571
SCOPE: Strategies to Combine PrEP With Prevention Efforts
A study testing Once daily Truvada® in people with HIV, run by FHI 360 at 2 sites in Kenya.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Once daily Truvada®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesKenya
- Study dates
- Jun 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Pregnant HIV antibody positive Using HIV post-exposure prophylaxis at enrollment
- -
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Family Health Options Kenya
Eldoret
Sex Workers Outreach Programme (SWOP)
Nairobi
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Once daily Truvada®
- Keywords
- HIV, PrEP, Female Sex Workers, Kenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once daily Truvada®Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Once daily Truvada® | Experimental | One tablet of Truvada (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily Receives: Drug: Once daily Truvada® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 11 months
PrEP Integration
Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers
Measured: 11 months
Secondary outcomes (9)
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
Measured: 11 months
drug level adherence
Assess the correlation between drug level adherence data and participant self-reported adherence data
Measured: 11 months
risk-taking behavior
Assess the impact of PrEP on HIV risk-taking behavior
Measured: 11 months
factors affecting Adherence
Identify factors associated with adherence to PrEP
Measured: 11 months
Support of prEP Adherence
Assess impact of adherence support by peer educators on PrEP adherence
Measured: 11 months
Contraceptive Use
Describe Contraceptive Use
Measured: 11 months
Resistance among Seroconverters
Assess resistance to TFV or FTC among seroconverters
Measured: 11 months
Birth Outcomes
Assess birth outcomes among women who choose to continue PrEP during pregnancy
Measured: 11 months
Tenofovir Concentrations
- Describe tenofovir concentrations among women who choose to continue PrEP during pregnancy
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Study is closed early due to withdrawal of funding. No study procedures were implemented.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health Options Kenya, Gilead Sciences, Institute of Tropical Medicine, Sex Workers Outreach Programme, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Jennifer Deese, MPH, Principal investigator, FHI 360Amy Corneli, Ph.D., Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832571
- Sponsor's protocol ID
- 391449
- Acronym
- SCOPE
- Status last verified
- Jul 2013
- First submitted
- 3 Apr 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Prospective Study of Strategies to Combine Pre-Exposure Prophylaxis (PrEP)With Prevention Efforts
- ClinicalTrials.gov ID
- NCT01832571
- Acronym / sponsor ID
- SCOPE / 391449
- Conditions
- HIV
- Keywords
- HIV, PrEP, Female Sex Workers, Kenya
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is closed early due to withdrawal of funding. No study procedures were implemented.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Family Health Options Kenya, Gilead Sciences, Institute of Tropical Medicine, Sex Workers Outreach Programme, University of North Carolina, Chapel Hill
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Once daily Truvada® | Experimental | Drug: Once daily Truvada®One tablet of Truvada (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant HIV antibody positive Using HIV post-exposure prophylaxis at enrollment
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Once daily Truvada®Also: 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. | Drug | Once daily Truvada® |
Primary outcome
Drug Adherence
Time frame: 11 months
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
Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers
9 secondary outcomes
Assess adherence
Time frame: 11 months
drug level adherence
Time frame: 11 months
risk-taking behavior
Time frame: 11 months
factors affecting Adherence
Time frame: 11 months
Support of prEP Adherence
Time frame: 11 months
Contraceptive Use
Time frame: 11 months
Resistance among Seroconverters
Time frame: 11 months
Birth Outcomes
Time frame: 11 months
Tenofovir Concentrations
Time frame: 11 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Deese, MPH principal investigator
FHI 360
Amy Corneli, Ph.D. principal investigator
FHI 360
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once daily Truvada® in people with HIV, run by FHI 360 at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Adherence (time frame: 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013.