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

Primary Purpose

HIV/AIDS

Status

Unknown status

Phase

Not Applicable

Locations

Malawi

Study Type

Interventional

Intervention

PrEP Cohort

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Bwaila HospitalRecruiting
Kawale Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PrEP Cohort

HIV Incidence

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Retention

Proportion of participants by risk group and age enrollment who are retained at 3, 6, 9, 12 months after enrollment in each study arm

HIV Incidence

Proportion of participants newly diagnosed HIV positive at 3, 6, 9, 12 months after enrollment in each study arm

Secondary Outcome Measures

Follow-up outcomes

Number of participants by follow-up outcomes ( Discontinue, dead, withdraw, lost to follow-up) for each study arm

Uptake

Number of clients enrolled in each study arm

Full Information

NCT ID

NCT04044235

First Posted

August 1, 2019

Last Updated

August 12, 2019

Sponsor

Lighthouse Trust

Collaborators

United States President's Emergency Plan for AIDS Relief, Ministry of Health, Malawi, Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04044235

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 25, 2019 (Actual)

Primary Completion Date

December 24, 2020 (Anticipated)

Study Completion Date

December 24, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lighthouse Trust

Collaborators

United States President's Emergency Plan for AIDS Relief, Ministry of Health, Malawi, Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A non- randomized study design being implemented in 2 facilities in Lilongwe Urban. The first component is a cross-sectional study of AGYW in which HIV testing counselors will offer HIV tests and assess HIV risk. A sample of AGYW testing HIV-negative and established to be at high risk will be consented to enroll in the PrEP study. 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. In the third component, AGYW who consent will be enrolled in a PrEP study. The PrEP study has two phases, which are, (i) a formative qualitative study involving AGYW and PrEP providers to understand factors and barriers to delivering PrEP to AGYW and (ii) a feasibility study of delivering PrEP to HIV negative AGYW. AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW.

Masking

Care Provider

Allocation

Non-Randomized

Enrollment

1032 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PrEP Cohort

Arm Type

Experimental

Arm Description

Arm Title

HIV Incidence

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PrEP Cohort

Intervention Description

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.

Primary Outcome Measure Information:

Title

Retention

Description

Proportion of participants by risk group and age enrollment who are retained at 3, 6, 9, 12 months after enrollment in each study arm

Time Frame

12 Months

Title

HIV Incidence

Description

Proportion of participants newly diagnosed HIV positive at 3, 6, 9, 12 months after enrollment in each study arm

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Follow-up outcomes

Description

Number of participants by follow-up outcomes ( Discontinue, dead, withdraw, lost to follow-up) for each study arm

Time Frame

12 months

Title

Uptake

Description

Number of clients enrolled in each study arm

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hannock Tweya, PhD

Phone

+265 1758940

Ext

220

htweya@lighthouse.org.mw

First Name & Middle Initial & Last Name or Official Title & Degree

Friday Pharaoh, BSc

Phone

+265 1758940

Ext

225

fpharaoh@lighthouse.org.mw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Phiri, PhD

Organizational Affiliation

Lighthouse Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bwaila Hospital

City

Lilongwe

State/Province

Central

Country

Malawi

Individual Site Status

Recruiting

Facility Name

Kawale Health Centre

City

Lilongwe

State/Province

Central

Country

Malawi

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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

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