Long-acting Injectable Cabotegravir for PrEPNCT07579754
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
A study testing Tracing Strategy in people with Long-acting Injectable Cabotegravir for PrEP and Oral Pre-Exposure Prophylaxis (PrEP), run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
- What is being tested?
- Tracing Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteMalawi
- Study dates
- 14 Jul 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Johns Hopkins Research Project Malawi
Blantyre
Sufia Dadabhai, PhD, MHS, +265 111 811 885, sufia@jhu.edu
Linda Nyondo-Mipando, PhD, RNM
About this study
Official title: 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.
Read the 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:
- Ascertain clinical and engagement outcomes among disengaged PrEP users
- Document experiences and perceptions of key stakeholders from PathToScale regarding program implementation and user retention
- Investigate factors contributing to discontinuation of PrEP
- 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).
- Being tested
- Tracing Strategy
- Keywords
- Implementation Science, Long-acting injectable cabotegravir for PrEP, Oral pre-exposure prophylaxis (PrEP), HIV, pre-exposure prophylaxis (PrEP), Lost-to-follow up (LTFU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracing StrategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tracing Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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).
Measured: Within 24 months of PrEP LTFU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start14 Jul 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-acting Injectable Cabotegravir for PrEPStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kamuzu University of Health Sciences, Johns Hopkins Research Project, Malawi, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Sheree Schwartz, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthLinda Nyondo-Mipando, PhD, RNM, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579754
- Sponsor's protocol ID
- IRB00034918
- Other IDs
- R01MH137795, P.1125-1975
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi
- ClinicalTrials.gov ID
- NCT07579754
- Acronym / sponsor ID
- IRB00034918
- Keywords
- Implementation Science, Long-acting injectable cabotegravir for PrEP, Oral pre-exposure prophylaxis (PrEP), HIV, pre-exposure prophylaxis (PrEP), Lost-to-follow up (LTFU)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kamuzu University of Health Sciences, Johns Hopkins Research Project, Malawi, Washington University School of Medicine
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Ascertain clinical and engagement outcomes among disengaged PrEP users
- Document experiences and perceptions of key stakeholders from PathToScale regarding program implementation and user retention
- Investigate factors contributing to discontinuation of PrEP
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Tracing StrategyParticipants will receive the SoC and tracing strategy to ascertain their PrEP outcome if they missed a visit. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracing StrategyParticipants 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. | Behavioural | Tracing Strategy |
Primary outcome
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.
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.
2 secondary outcomes
Number of clients traced with any drug level in dried blood sample
Time frame: Immediately after the tracing intervention
Participant re-engagement preferences estimated by discrete choice experiment
Time frame: Within 24 months of PrEP LTFU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheree Schwartz, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
Linda Nyondo-Mipando, PhD, RNM principal investigator
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracing Strategy in people with Long-acting Injectable Cabotegravir for PrEP and Oral Pre-Exposure Prophylaxis (PrEP), run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Abdulrahman, MSPH (+ 1 443-983-4376, aabdul23@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP users LTFU (Prep Engagement) (time frame: From 3 months LTFU up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.