HIV Incidence in a Cohort of and Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women in Urban Lilongwe, Central Malawi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- Lighthouse Trust
- Enrollment
- 1032
- Locations
- 2
- Primary Endpoint
- HIV Incidence
- Last Updated
- 6 years ago
Overview
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 facilities in Lilongwe, Malawi. The primary objective of the study is to assess the feasibility, acceptability, tolerability and cost of delivering PrEP among high-risk AGYW aged 18-24 years and healthcare providers in urban Lilongwe. Secondary objectives are (i) to assess the program's ability to enroll and retain a PrEP cohort for one year and (ii) measure the incidence of HIV infection among high risk AGYW in urban Lilongwe among women who decline to enroll in the PrEP study (these will be offered enrollment in the HIV incidence study).
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 communities and two public facilities in Lilongwe, Malawi. The primary objectives are to; determine HIV prevalence among all AGYW identified as potentially at high risk of HIV infection in urban Lilongwe; assess the HIV program's ability to enroll and retain the PrEP cohort for one year; assess participants' and providers' perceptions of the barriers and facilitators for providing PrEP to inform implementation of PrEP study and future interventions and assess the cost of PrEP delivery in the routine HIV program. Secondary Objectives: 1. To measure annual HIV incidence in a prospective cohort of HIV-negative AGYW identified as potentially at high risk of HIV infection but declined to enroll in PrEP cohort study in urban Lilongwe. 2. To measure annual HIV incidence among HIV-negative AGYW who enrolled in PrEP cohort study in urban Lilongwe. 3. To determine risk factors for HIV in a cohort of AGYW recruited in the prospective cohort study
Investigators
Sam Phiri, PhD, MSc, DCM
Executive Director
Lighthouse Trust
Eligibility Criteria
Inclusion Criteria
- •Eligibility criteria for the cross-sectional study
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
HIV Incidence
Time Frame: 12 Months
Proportion of participants newly diagnosed HIV positive at 3, 6, 9, 12 months after enrollment in each study arm
Retention
Time Frame: 12 Months
Proportion of participants by risk group and age enrollment who are retained at 3, 6, 9, 12 months after enrollment in each study arm
Secondary Outcomes
- Uptake(12 months)
- Follow-up outcomes(12 months)