BetterInfo on Women's PrEP Choices and Outcomes in Malawi

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: Not yet recruiting
• Conditions: Long-acting Injectable Cabotegravir for PrEP; Oral Pre-Exposure Prophylaxis (PrEP)
• Intervention / Treatment: Behavioral: Tracing Strategy

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: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
PrEP users LTFU (Prep Engagement)	number of PrEP users discontinued PrEP and are no longer at high risk / number of LTFU PrEP users traced.; number of PrEP users discontinued PrEP and remain at high risk / number of LTFU PrEP users traced.; number of PrEP users on PrEP but transferred site (silent transfers) / number of LTFU PrEP users traced.; number of PrEP users back on PrEP but had an interruption / number of LTFU PrEP users traced.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clients traced with any drug level in dried blood sample	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	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

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute of Mental Health (NIMH); Washington University School of Medicine; Kamuzu University of Health Sciences; Johns Hopkins Research Project, Malawi
• Investigators: 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

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Implementation Science; pre-exposure prophylaxis (PrEP); Long-acting injectable cabotegravir for PrEP; Oral pre-exposure prophylaxis (PrEP); Lost-to-follow up (LTFU)
• Other Study ID 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