NCT04044235

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 1, 2019

Last Update Submit

August 12, 2019

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • 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

    12 Months

  • HIV Incidence

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

    12 Months

Secondary Outcomes (2)

  • Follow-up outcomes

    12 months

  • Uptake

    12 months

Study Arms (2)

PrEP Cohort

EXPERIMENTAL

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.

Behavioral: PrEP Cohort

HIV Incidence

NO INTERVENTION

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.

Interventions

PrEP CohortBEHAVIORAL

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.

PrEP Cohort

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • HIV positive
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bwaila Hospital

Lilongwe, Central Region, Malawi

RECRUITING

Kawale Health Centre

Lilongwe, Central Region, Malawi

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sam Phiri, PhD

    Lighthouse Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannock Tweya, PhD

CONTACT

+265 1758940htweya@lighthouse.org.mw

Friday Pharaoh, BSc

CONTACT

+265 1758940fpharaoh@lighthouse.org.mw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

June 25, 2019

Primary Completion

December 24, 2020

Study Completion

December 24, 2020

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

MA(2)