Status:
UNKNOWN
Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women
Lead Sponsor:
Lighthouse Trust
Collaborating Sponsors:
United States President's Emergency Plan for AIDS Relief
Ministry of Health, Malawi
Conditions:
HIV/AIDS
Eligibility:
FEMALE
18-24 years
Phase:
NA
Brief Summary
To provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facil...
Detailed Description
The main goal of the study is to provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city co...
Eligibility Criteria
Inclusion
- Eligibility criteria for the cross-sectional study
- Female
- Consent to be counselled and tested for HIV
- Between 18 and 24 years old
- Ongoing HIV risk according to the risk Assessment guide
- Participated in the cross-sectional screening study or meets the eligibility criteria for the cross-sectional study
- Willing to provide written informed consent to participate in the HIV incidence study
- Accesses services at a mobile or fixed clinic in the defined catchment area
- Not planning to relocate in the next 12 months Eligibility criteria for the prospective PrEP for AGYW
- Participated in the cross-sectional study
- HIV-negative
- Answers yes to any two questions from the PrEP screening tool
- Willing and able to adhere to daily PrEP
- Willing to provide written informed consent to participate in the PrEP study
- Accesses services at a mobile or fixed clinic in the defined catchment area
- Not planning to relocate in the next 12 months
- Eligibility criteria for focus group discussions for PrEP providers
- Provided PrEP for at least 3 months
- Trained nurse
- Orientated in PrEP and study procedures
Exclusion
- Exclusion criteria for the prospective HIV incidence phase
- • HIV positive
- Exclusion criteria for PrEP for AGYW
- Under 18 years or older than 24 years at enrollment (including AGYW aged 24 years at enrolment)
- Breastfeeding women
- Already taking oral or injectable PrEP through another study
- Current or past history of renal or liver disease
- Clients on multi-drug resistant tuberculosis (MDR-TB) medications
- Signs of acute HIV infection. The client would be asked to return after 3 months for a re-evaluation
- FSW \<35kg
- Known allergy to tenofovir disoproxil fumarate (TDF) and/or emtricitabine (FTC);
- Unwilling or unable to return for 3-monthly HIV testing, counselling and safety monitoring visits or planning to relocate to another geographic area during the period of the study.
- Blood creatinine clearance (Cr Cl) \<60ml/min
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2020
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT04044235
Start Date
June 25 2019
End Date
December 24 2020
Last Update
August 14 2019
Active Locations (2)
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1
Bwaila Hospital
Lilongwe, Central Region, Malawi
2
Kawale Health Centre
Lilongwe, Central Region, Malawi