Improving Perceptions of HIV RiskNCT03565575
Manicaland PrEP Uptake Through Interactive Counselling Trial
A study testing Interactive tablet-based quiz in people with Improving Perceptions of HIV Risk and Improving Uptake of Pre-exposure Prophylaxis for HIV, run by Simon Gregson at 8 sites in Zimbabwe.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV
- What is being tested?
- Interactive tablet-based quiz
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,055 participants
- Where
- 8 sitesZimbabwe
- Study dates
- 7 Jul 2018to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Age 18-24 years
Who cannot join
- Participants testing HIV-positive at baseline
- Self-reporting taking PrEP at baseline
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Zimbabwe8 sites
Manicaland Centre for Public Health Research
Bonda, Manicaland Province
Manicaland Centre for Public Health Research
Eastern Highlands, Manicaland Province
Manicaland Centre for Public Health Research
Hobhouse, Manicaland Province
Manicaland Centre for Public Health Research
Honde, Manicaland Province
Manicaland Centre for Public Health Research
Nyanga
Manicaland Centre for Public Health Research
Nyazura, Manicaland Province
Manicaland Centre for Public Health Research
Sakubva, Manicaland Province
Manicaland Centre for Public Health Research
Selbourne, Manicaland Province
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Interactive tablet-based quiz
- Keywords
- Pre-Exposure Prophylaxis (PrEP) for HIV, Risk perception, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive tablet-based quizBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive tablet-based quiz | Experimental | Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session. Receives: Behavioral: Interactive tablet-based quiz |
| Control arm | No intervention | No intervention will be administered to the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Pre-exposure prophylaxis for HIV
The proportion of women taking up PrEP within 6 months measured with biomarkers of plasma ARV presence.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start7 Jul 2018
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Improving Perceptions of HIV RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- matched-cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Gregson
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Simon Gregson, Imperial College London
- Investigators
- Simon Gregson, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565575
- Sponsor's protocol ID
- P67251_PrEP
- Other IDs
- 1R01MH114562-01
- Status last verified
- Sep 2023
- First submitted
- 11 Jun 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31791405
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03565575
- Acronym / sponsor ID
- P67251_PrEP
- Keywords
- Pre-Exposure Prophylaxis (PrEP) for HIV, Risk perception, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,055 participants (actual)
- Lead sponsor
- Simon GregsonUniversity, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- matched-cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interactive tablet-based quiz | Experimental | Behavioral: Interactive tablet-based quizIndividuals participate in an interactive tablet-based risk perception and PrEP counselling information session. |
| Control arm | No intervention | –No intervention will be administered to the control arm |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women
- Age 18-24 years
Key exclusion criteria (2 listed)
- Participants testing HIV-positive at baseline
- Self-reporting taking PrEP at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive tablet-based quizIntervention 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. | Behavioural | Interactive tablet-based quiz |
Primary outcome
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.
1 secondary outcome
Changes in perception of risk of HIV from age-disparate partnerships
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 31791405Thomas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Gregson, PhD principal investigator
Imperial College London
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive tablet-based quiz in people with Improving Perceptions of HIV Risk and Improving Uptake of Pre-exposure Prophylaxis for HIV, run by Simon Gregson at 8 sites in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of Pre-exposure prophylaxis for HIV (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.