- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
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:
- 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.
- To measure annual HIV incidence among HIV-negative AGYW who enrolled in PrEP cohort study in urban Lilongwe.
- To determine risk factors for HIV in a cohort of AGYW recruited in the prospective cohort study
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hannock Tweya, PhD
- Phone Number: 220 +265 1758940
- Email: htweya@lighthouse.org.mw
Study Contact Backup
- Name: Friday Pharaoh, BSc
- Phone Number: 225 +265 1758940
- Email: fpharaoh@lighthouse.org.mw
Study Locations
-
-
Central
-
Lilongwe, Central, Malawi
- Recruiting
- Bwaila Hospital
-
Lilongwe, Central, Malawi
- Recruiting
- Kawale Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PrEP Cohort
AGYW HIV-negative and established to be at high risk will be consented to enroll in the PrEP study.
AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW.
|
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.
|
No Intervention: HIV Incidence
HIV Incidence Cohort: In the second component, AGYW who refuse PrEP will be consented to enroll in an HIV incidence cohort study and will be followed every 3 months for 12 months to determine HIV incidence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 Months
|
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
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Follow-up outcomes
Time Frame: 12 months
|
Number of participants by follow-up outcomes ( Discontinue, dead, withdraw, lost to follow-up) for each study arm
|
12 months
|
Uptake
Time Frame: 12 months
|
Number of clients enrolled in each study arm
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- PrEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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