Manicaland PrEP Uptake Through Interactive Counselling Trial

NCT ID: NCT03565575

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1055 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-07
• Study Completion Date: 2021-01-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Interactive tablet-based quiz

Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session.

Group Type: EXPERIMENTAL

Interactive tablet-based quiz

Intervention Type: BEHAVIORAL

Intervention participants play an interactive tablet based quiz including the following information components:

1. Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours.

2. 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.

Control arm

No intervention will be administered to the control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interactive tablet-based quiz

Intervention participants play an interactive tablet based quiz including the following information components:

1. Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours.

2. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women
• Age 18-24 years

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Research and Training Institute, Zimbabwe

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

London School of Economics and Political Science

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Simon Gregson

OTHER

Sponsor Role: lead

Responsible Party

Simon Gregson

Professor of Demography and Behavioural Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Simon Gregson, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Manicaland Centre for Public Health Research

Bonda, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Eastern Highlands, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Hobhouse, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Honde, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Nyazura, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Sakubva, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Selbourne, Manicaland Province, Zimbabwe

Manicaland Centre for Public Health Research

Nyanga, , Zimbabwe

Countries

Zimbabwe

References

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.

Reference Type: DERIVED

PMID: 31791405 (View on PubMed)

Other Identifiers

1R01MH114562-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P67251_PrEP

Identifier Type: -

Identifier Source: org_study_id