Manicaland PrEP Uptake Through Interactive Counselling Trial

Simon Gregson

Status: Completed

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

Treatments: Behavioral: Interactive tablet-based quiz

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03565575

1R01MH114562-01 (U.S. NIH Grant/Contract)

P67251_PrEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,055 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women
• Age 18-24 years

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,055 participants in 2 patient groups

Interactive tablet-based quiz

Experimental group

Description:

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

Treatment:

Behavioral: Interactive tablet-based quiz

Control arm

No Intervention group

Description:

No intervention will be administered to the control arm