Manicaland PrEP Uptake Through Interactive Counselling Trial

Improving Perceptions of HIV Risk Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565575
• Other study ID #: P67251_PrEP
• Secondary ID: 1R01MH114562-01
• Status: Completed
• Phase: N/A
• Start date: July 7, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1055
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Women
• Age 18-24 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Improving Perceptions of HIV Risk
• Improving Uptake of Pre-exposure Prophylaxis for HIV

Intervention

Behavioral:
• Interactive tablet-based quiz
Intervention participants play an interactive tablet based quiz including the following information components: Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours. Interactive counselling on key facts around PrEP, its usability and local availability All individuals will have the option to sign up for contact by a nurse from the health clinic to discuss PrEP further and make an appointment for a visit. Participants will also be given a PrEP referral letter which they can present directly at one of the participating study clinics to begin PrEP. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.

Locations

Country	Name	City	State
Zimbabwe	Manicaland Centre for Public Health Research	Bonda	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Eastern Highlands	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Hobhouse	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Honde	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Nyanga
Zimbabwe	Manicaland Centre for Public Health Research	Nyazura	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Sakubva	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Selbourne	Manicaland

Sponsors (5)

Lead Sponsor	Collaborator
Simon Gregson	Biomedical Research and Training Institute, Zimbabwe, London School of Economics and Political Science, National Institute of Mental Health (NIMH), University of Copenhagen

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of Pre-exposure prophylaxis for HIV	The proportion of women taking up PrEP within 6 months measured with biomarkers of plasma ARV presence.	6 months
Secondary	Changes in perception of risk of HIV from age-disparate partnerships	Risk perception with be measured in a follow-up survey at 6 months with the following specific definitions; Proportion of women correctly reporting a 25-29 year old man is more likely infected with HIV in Manicaland than a 15-19 year old man; Proportion of women correctly reporting a 25-29 year old man is more likely infected with HIV in Manicaland than a 15-19 year old woman	6 months