Clinical trial NCT03565575: Manicaland PrEP Uptake Through Interactive Counselling Trial
Official title: Improving Risk Perception and Uptake of Pre-exposure Prophylaxis (PrEP) Through Interactive Feedback Based Counselling (and Community Engagement) in Young Women in Manicaland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improving Perceptions of HIV Risk
Improving Uptake of Pre-exposure Prophylaxis for HIV
Keywords: Pre-Exposure Prophylaxis (PrEP) for HIV
Risk perception
HIV
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Biomedical Research and Training Institute, Zimbabwe
name: University of Copenhagen
name: London School of Economics and Political Science
name: National Institute of Mental Health (NIMH)
First posted: 2018-06-21
Enrollment: 1055
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: matched-cluster randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Primary Objective:

The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of PrEP on PrEP uptake within 6 months in adolescent girls and young women (AGYW) aged 18-24 years.

Hypothesis:

Correcting misperceptions of risks of HIV infection and off-setting ambiguity effects about the availability, usability and efficacy of PrEP, through localized, interactive, tablet-based counselling, will increase uptake of PrEP in HIV-negative AGYW.

Study outcomes:

The primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of women taking up PrEP within 6 months measured with biomarkers of plasma antiretroviral (ARV) drug presence.

Detailed description: With 6 clusters per arm, mean cluster size of 48 individuals, with co-efficient of variation in outcomes between 0.15 to 0.55, the trial will have 80% power to detect difference of 5 - 9 percentage points when baseline PrEP uptake is assumed to be 1%.

Primary analysis:

A two-stage intention-to-treat (ITT) analysis of cluster level summaries will be used. The parameter of interest is the adjusted risk difference in primary and secondary outcomes.

In the first stage, Logistic regression will be used to adjust for confounding variables at the individual level. The model will be fitted using data from both trial arms. The regression model will include terms for the covariates of interest and pair but not trial arm. Adjustment variables will include age group (\<20, 20-24), highest level of education completed, marital status and baseline measures of outcomes. In the second stage, a formal statistical comparison for differences in observed versus expected uptake by arm will be conducted using a two-sided paired significance test with α=0.05.

Secondary analysis:

In secondary analysis, the complier average causal effect (CACE) will be estimated using an instrumental variables approach. The parameter of interest is the adjusted risk difference in primary and secondary outcomes.

Heterogeneity by age and baseline levels of risk and time preferences will also be estimated.

Eligibility criteria: Inclusion Criteria:

* Women
* Age 18-24 years

Exclusion Criteria:

* Participants testing HIV-positive at baseline
* Self-reporting taking PrEP at baseline

Primary outcomes:
measure: Uptake of Pre-exposure prophylaxis for HIV
timeFrame: 6 months
Secondary outcomes:
measure: Changes in perception of risk of HIV from age-disparate partnerships
timeFrame: 6 months
Other outcomes:
Locations:
city: Bonda
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Eastern Highlands
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Hobhouse
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Honde
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Nyazura
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Sakubva
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Selbourne
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Nyanga
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
Study officials:
affiliation: Imperial College London
name: Simon Gregson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas R, Skovdal M, Galizzi MM, Schaefer R, Moorhouse L, Nyamukapa C, Maswera R, Mandizvidza P, Hallett TB, Gregson S. Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial. Trials. 2019 Dec 2;20(1):668. doi: 10.1186/s13063-019-3791-8.