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

NCT04044235 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2019-08-14

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • United States President's Emergency Plan for AIDS Relief

    collaborator FED

  • Ministry of Health, Malawi

    collaborator OTHER_GOV

  • Centers for Disease Control and Prevention

    collaborator FED

  • Lighthouse Trust

    lead OTHER

Principal Investigators

  • Sam Phiri, PhD · Lighthouse Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-12-24
Completion
2020-12-24

Countries

  • Malawi

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044235 on ClinicalTrials.gov