Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 2:38 PM
Study NCT ID:
NCT04044235
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women
Sponsor:
Lighthouse Trust
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: