NCT04044235

Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,032 (estimated)
• Sponsor: Lighthouse Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
BEHAVIORAL	PrEP Cohort	AGYW who are eligible for PrEP will be educated about the risk and benefits. For AGYW (aged 18-24 years) who consent to PrEP, an ART provider (nurse or clinician) certified by the MOH will provide PrEP (package of disoproxil fumarate/emtricitabine (Truvada)) on the same day that the client is determined eligible. Peer navigators will ensure linkage to facilities for follow-up care. The initial follow-up visit will occur one month from PrEP initiation to ensure that the client is tolerating the regimen and to answer any questions, with three-month follow-up visits thereafter.

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-12-24
• Completion: 2020-12-24
• First posted: 2019-08-05
• Last updated: 2019-08-14

Locations

2 sites across 1 country: Malawi