BetterInfo on Women's PrEP Choices and Outcomes in Malawi

May 6, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aims to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable (LAI) PrEP alongside oral PrEP among women in Malawi. The Broad Objective of this study is to use the adapted BetterInfo tracing approach to evaluate PrEP choices and oral and long-acting injectable PrEP use over time among women lost-to-follow up (LTFU) within the prior 2 years in Blantyre, Malawi and preferences for PrEP re-engagement strategies. Concurrently with this tracing approach, the study team will assess decision making among disengaged women and the women's providers.

The study has Specific Objectives:

  1. Ascertain clinical and engagement outcomes among disengaged PrEP users
  2. Document experiences and perceptions of key stakeholders from PathToScale regarding program implementation and user retention
  3. Investigate factors contributing to discontinuation of PrEP
  4. Evaluate the impact of BetterInfo tracing approach on re-engaging former PrEP users and improving long term retention outcomes.

These objectives will be achieved through tracing a random sample of women LTFU from oral and injectable PrEP services from implementing sites in Blantyre, Malawi for whom outcomes are unknown, and which are achieved through two data collection activities. The first comprises cross-sectional quantitative survey including stated preference assessments with discontinued (former) PrEP users. The second comprises in-depth qualitative interviews (IDIs) with sub-sets of the traced discontinued PrEP users, as well as healthcare providers/ implementing partner stakeholders. Activities from this study will inform the design of strategies for optimizing PrEP continuation and re-engagement to achieve implementation and prevention impact for women in Malawi.

The study team will utilize epidemiological principles to sample women on PrEP lost to follow-up with unknown outcomes with the purpose of utilizing this sample to re-estimate PrEP outcomes across all women lost on PrEP in the facilities. Using a sampling and tracing approach the study team will then leverage a sequential mixed methods design. First, the study team will conduct a quantitative study among women traced, including a questionnaire, HIV outcomes assessment and stated preference questions. Then a subset of women will be included, alongside healthcare providers, in follow-up qualitative in-depth interviews to gain greater insights into women's PrEP journeys and the circumstances and considerations around discontinuation of PrEP and re-engagement on PrEP. Study processes will take approximately 2 years to successfully trace the targeted sample.

The study design leverages the existing infrastructure from the PathToScale study (NCT06319105) and mimics the approach used in Zambia, with human-centered design adaption from the formative phase of the study. The study team will leverage existing Electronic Medical Records (EMR) from PathToScale at clinics to identify all clients initiating PrEP during the PathToScale study who have become LTFU, (i.e., 3 months late for a return visit) in accordance with Ministry of Health (MOH) guidelines. The list of clients LTFU will be randomly sorted using statistical software and consecutively sampled for tracing; this process will be stratified by site proportional to the number of female PrEP clients.

Additionally, the study team will prospectively screen PrEP clients at clinics prior to loss to follow-up. Potential participants will be informed of the study and confirm follow-up phone contacts for themselves and any other individuals the participant would be comfortable being contacted. The study team will also request permission to share home locator information and if participants are comfortable, the study team will seek the participant's permission for in-person follow-up should the participant be lost to followup (LTFU) and randomly selected for the study. In all cases the study team will attempt to contact via phone a client at least three times prior to initiating home-based tracing and only if verbal consent was indicated for this visit.

The study team will classify the following outcomes of those participants contacted/traced: (1) discontinued PrEP and no longer at increased acquisition risk; (2) discontinued PrEP and remaining at high risk for HIV acquisition; (3) on PrEP but transferred sites/on PrEP at the same site but data error identified; (4) re-initiated PrEP after an interruption; and (5) newly acquired HIV cases (those known to the client already and those identified through the study).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Amal Abdulrahman, MSPH
  • Phone Number: + 1 443-983-4376
  • Email: aabdul23@jh.edu

Study Contact Backup

  • Name: Sheree Schwartz, PhD, MPH
  • Phone Number: +1 443-983-2464
  • Email: sschwartz@jhu.edu

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Johns Hopkins Research Project Malawi
        • Contact:
          • Sufia Dadabhai, PhD, MHS
          • Phone Number: +265 111 811 885
          • Email: sufia@jhu.edu
        • Principal Investigator:
          • Linda Nyondo-Mipando, PhD, RNM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care (SoC)
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.
Active Comparator: Tracing Strategy
Participants will receive the SoC and tracing strategy to ascertain their PrEP outcome if they missed a visit.
Behavioral: Tracing Strategy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP users LTFU (Prep Engagement)
Time Frame: From 3 months LTFU up to 24 months
  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)
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of clients traced with any drug level in dried blood sample
Time Frame: Immediately after the tracing intervention
Measured by the number of clients traced with any drug level in their blood / number of PrEP clients traced. PrEP drug blood levels will be measured biologically through dried blood samples among those lost to follow up and traced.
Immediately after the tracing intervention
Participant re-engagement preferences estimated by discrete choice experiment
Time Frame: Within 24 months of PrEP LTFU
Assess preferences through discrete choice experiment methods (best worst scaling) for re-engaging in PrEP care among those at HIV risk. Evaluated using count analysis and best-worst scaling scores for individuals (difference in number of times item scored best and worst number of times item appears and aggregate score for the population (mean population score rescaled to 100, presented as forest plots).
Within 24 months of PrEP LTFU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Kamuzu University of Health Sciences
Johns Hopkins Research Project, Malawi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheree Schwartz, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Linda Nyondo-Mipando, PhD, RNM, Kamuzu University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00034918
  • R01MH137795 (U.S. NIH Grant/Contract)
  • P.1125-1975 (Other Identifier: COMREC IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Will be available beginning 1 year after study has ended following data cleaning, analysis and publication and ending 1 year afterwards.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Long-acting Injectable Cabotegravir for PrEP

Clinical Trials on Tracing Strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings