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Manicaland PrEP Uptake Through Interactive Counselling Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03565575
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Biomedical Research and Training Institute, Zimbabwe
University of Copenhagen
London School of Economics and Political Science
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Simon Gregson, Imperial College London

Study Description
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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.


Condition or disease Intervention/treatment Phase
Improving Perceptions of HIV Risk Improving Uptake of Pre-exposure Prophylaxis for HIV Behavioral: Interactive tablet-based quiz Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 7, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Interactive tablet-based quiz
Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session.
 Behavioral: 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.
No Intervention: Control arm
No intervention will be administered to the control arm


Outcome Measures
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Primary Outcome Measures :
  1. Uptake of Pre-exposure prophylaxis for HIV [ Time Frame: 6 months ]
    The proportion of women taking up PrEP within 6 months measured with biomarkers of plasma ARV presence.


Secondary Outcome Measures :
  1. Changes in perception of risk of HIV [ Time Frame: 6 months ]
    Risk perception with be measured in a follow-up survey at 6 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women
  • Age 18-24 years

Exclusion Criteria:

  • Participants testing HIV-positive at baseline
  • Self-reporting taking PrEP at baseline
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565575


Locations
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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
Nyazura, Manicaland, Zimbabwe
Manicaland Centre for Public Health Research
Sakubva, Manicaland, Zimbabwe
Manicaland Centre for Public Health Research
Selbourne, Manicaland, Zimbabwe
Manicaland Centre for Public Health Research
Nyanga, Zimbabwe
Sponsors and Collaborators
Simon Gregson
Biomedical Research and Training Institute, Zimbabwe
University of Copenhagen
London School of Economics and Political Science
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Simon Gregson, PhD Imperial College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Simon Gregson, Professor of Demography and Behavioural Science, Imperial College London
ClinicalTrials.gov Identifier: NCT03565575    
Other Study ID Numbers: P67251_PrEP
1R01MH114562-01 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Gregson, Imperial College London:
Pre-Exposure Prophylaxis (PrEP) for HIV
Risk perception
HIV