BetterInfo on Women's PrEP Choices and Outcomes in Malawi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-110
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tracing Strategy
BehavioralParticipants 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.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SoC)No intervention 0 interventions
Group B: Tracing StrategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From 3 months LTFU up to 24 months2
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
Immediately after the tracing intervention2
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).
Time frame
Within 24 months of PrEP LTFUSponsors and contacts
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Kamuzu University of Health Sciences
Collaborator
Johns Hopkins Research Project, Malawi
Collaborator
Washington University School of Medicine
Collaborator
Source ClinicalTrials.gov