NCT07579754

Brief Summary

The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress2%
May 2026Apr 2029

First Submitted

Initial submission to the registry

April 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Long-acting Injectable Cabotegravir for PrEPOral Pre-Exposure Prophylaxis (PrEP)

Keywords

Implementation ScienceLong-acting injectable cabotegravir for PrEPOral pre-exposure prophylaxis (PrEP)HIVpre-exposure prophylaxis (PrEP)Lost-to-follow up (LTFU)

Outcome Measures

Primary Outcomes (2)

  • PrEP users LTFU (Prep Engagement)

    1. number of PrEP users discontinued PrEP and are no longer at high risk / number of LTFU PrEP users traced. 2. number of PrEP users discontinued PrEP and remain at high risk / number of LTFU PrEP users traced. 3. number of PrEP users on PrEP but transferred site (silent transfers) / number of LTFU PrEP users traced. 4. number of PrEP users back on PrEP but had an interruption / number of LTFU PrEP users traced. 5. number of PrEP users newly acquired HIV / number of LTFU PrEP users traced.

    From 3 months LTFU up to 24 months

  • LTFU PrEP users traced who returned (Impact of tracing on return)

    Assess the impact of tracing on 6-month return/re-engagement in PrEP care. Measured by the number of LTFU PrEP users traced who returned / number of LTFU PrEP users traced.

    6 months

Secondary Outcomes (2)

  • Number of clients traced with any drug level in dried blood sample

    Immediately after the tracing intervention

  • Participant re-engagement preferences estimated by discrete choice experiment

    Within 24 months of PrEP LTFU

Study Arms (2)

Standard of Care (SoC)

NO INTERVENTION

Participants will receive standard of care (SoC) per Ministry of Health national guidelines of PrEP counseling, national program quality improvement activities, and follow up text messages and phone calls after missed visit.

Tracing Strategy

ACTIVE COMPARATOR

Participants will receive the SoC and tracing strategy to ascertain their PrEP outcome if they missed a visit.

Behavioral: Tracing Strategy

Interventions

Tracing StrategyBEHAVIORAL

Participants will receive the SoC per national guidelines and the tracing strategy. The purpose of this intervention is to ascertain the PrEP outcome of clients who have become LTFU (3 months late for a follow-up visit. The strategy includes 1) phone tracing and 2) field tracing with consent.

Tracing Strategy

Eligibility Criteria

Age18 Years - 110 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPer funder requirements for this award, only women are included in the sample.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The population for this research includes women aged 18 years or older at risk of HIV who initiated injectable or oral PrEP at one of the 20 Blantyre sites supported through PathToScale. PathToScale supports various types of facilities including public health clinics, drop-in centers for prioritized populations (DICs), and private hospitals/clinics.
  • Those eligible for sampling are as follows:
  • Adult women ≥18 years; and
  • Initiated PrEP (injectable or oral) at the implementing facilities and lost to follow up within prior 2 years prior to sampling; and
  • Lost-to-follow-up (missed their PrEP visit by ≥3 months and for whom outcomes are unknown); and
  • Has a registered phone number for contact
  • Those eligible for tracing are as follows:
  • Women sampled per eligibility criteria above; and
  • Women who have indicated permission for in-person follow-up
  • Health Care Providers, Implementing Partners, Ministry of Health (MOH) Stakeholers
  • providers and implementing partners from PathtoScale, and Ministry of Health stakeholders will be consented to participate in in-depth-interviews

You may not qualify if:

  • Those excluded from sampling or tracing include:
  • Women who have an EMR record of a documented case of discontinuation of PrEP in consultation with a provider; or
  • Women who are known to have died; or
  • Women who have EMR documented transfers out of PathToScale supported facilities; or
  • Women refusing follow-up via phone on their ScanForm; or
  • Women refusing follow-up in person (during phone tracing); or
  • Women who do not speak Chichewa or English; or
  • Men (excluded from client interviews only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Research Project Malawi

Blantyre, Malawi

Location

Study Officials

  • Sheree Schwartz, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Linda Nyondo-Mipando, PhD, RNM

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Abdulrahman, MSPH

CONTACT

+ 1 443-983-4376aabdul23@jh.edu

Sheree Schwartz, PhD, MPH

CONTACT

+1 443-983-2464sschwartz@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a parallel design with all facilities implementing the BetterInfo tracing approach simultaneously and a random sample of individuals sampled for tracing who will be compared to those who were not sampled.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified data will be available from the individual-level survey data through an individual login system, requiring registration; discrete choice experiments and statistical code created for the purpose of the study (written in Stata or R pending the analyses) will be shared publicly on the data sharing platform. Qualitative data will not be shared to protect participants' confidentiality.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Will be available beginning 1 year after study has ended following data cleaning, analysis and publication and ending 1 year afterwards.
Access Criteria
Access will only be granted to approved investigators upon request through a publicly available data request form. All data requests will be reviewed and considered by the investigative team and overseen by the Principal Investigators.
More information

Locations

MA(1)