HIV/AIDSNCT03868644
The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya
A study testing Voluntary Counseling and Testing for HIV (VCT) and Condoms in people with HIV/AIDS and HSV-2 Infection, run by Abdul Latif Jameel Poverty Action Lab.
Trial summary
The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV/AIDS, HSV-2 Infection
- What is being tested?
- Voluntary Counseling and Testing for HIV (VCT) and Condoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,646 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2009to 1 Jul 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.
Who cannot join
- Youth sampled for the study who do not consent to participate.
About this study
Official title: HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya
The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of HIV.
This research study aims to examine, through a large randomized controlled trial, the impact of two HIV prevention strategies among a youth population in Kenya: Voluntary Counseling and Testing for HIV (VCT), and condom distribution.
- Conditions
- HIV/AIDS, HSV-2 Infection
- Being tested
- Voluntary Counseling and Testing for HIV (VCT), Condoms
- Keywords
- Youth, Kenya, Voluntary Counseling and Testing for HIV, Condoms, HIV prevention, HSV-2
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary Counseling and Testing for HIV (VCT)Behavioural
Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP).
CondomsBehavioural
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
| Study group | Role | What they receive |
|---|---|---|
| Voluntary Counseling and Testing for HIV (VCT) | Experimental | Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP). Receives: Behavioral: Voluntary Counseling and Testing for HIV (VCT) |
| Condoms | Experimental | Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge. Receives: Behavioral: Condoms |
| VCT and Condoms | Experimental | Youth are offered both VCT and condoms. Receives: Behavioral: Voluntary Counseling and Testing for HIV (VCT); Behavioral: Condoms |
| Control | No intervention | No intervention is provided (beyond the standard available HIV prevention services within the area) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSV-2 prevalence
Assessed via a blood test
Measured: 2 years post-intervention
Secondary outcomes (7)
% of youth who have high HIV knowledge
Assessed via a questionnaire
Measured: 2 years post-intervention
% of youth who did not use a condom at last intercourse
Assessed via a questionnaire
Measured: 2 years post-intervention
% of youth who reported having an STI or symptoms of an STI
Assessed via a questionnaire
Measured: 2 years post-intervention
% of youth who report ever being pregnant
Assessed via a questionnaire
Measured: 2 years post-intervention
Number of sexual partners
Assessed via a questionnaire
Measured: 2 years post-intervention
HIV prevalence
Assessed via a blood test
Measured: 2 years post-intervention
% of youth who have accepting attitudes towards people living with HIV (PLHIV)
Assessed via a questionnaire
Measured: 2 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Feb 2009
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
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 HIV/AIDSStudies 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
- Masking
- None (open label)
- Enrolment
- 10,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Latif Jameel Poverty Action Lab
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action
- Responsible party
- Sponsor
- Investigators
- Esther Duflo, Principal investigator, Massachusetts Institute of TechnologyPascaline Dupas, Principal investigator, Stanford UniversityVandana Sharma, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868644
- Sponsor's protocol ID
- 0809002873R010
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duflo E, Dupas P, Ginn T, Barasa GM, Baraza M, Pouliquen V, Sharma V. HIV prevention among youth: A randomized controlled trial of voluntary counseling and testing for HIV and male condom distribution in rural Kenya. PLoS One. 2019 Jul 30;14(7):e0219535. doi: 10.1371/journal.pone.0219535. eCollection 2019.
PubMed 31361767
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya
- ClinicalTrials.gov ID
- NCT03868644
- Acronym / sponsor ID
- 0809002873R010
- Conditions
- HIV/AIDS, HSV-2 Infection
- Keywords
- Youth, Kenya, Voluntary Counseling and Testing for HIV, Condoms, HIV prevention, HSV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,646 participants (actual)
- Lead sponsor
- Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 11 Mar 2019 (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.
The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of HIV.
This research study aims to examine, through a large randomized controlled trial, the impact of two HIV prevention strategies among a youth population in Kenya: Voluntary Counseling and Testing for HIV (VCT), and condom distribution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Voluntary Counseling and Testing for HIV (VCT) | Experimental | Behavioral: Voluntary Counseling and Testing for HIV (VCT)Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP). |
| Condoms | Experimental | Behavioral: CondomsYouth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge. |
| VCT and Condoms | Experimental | Behavioral: Voluntary Counseling and Testing for HIV (VCT), Behavioral: CondomsYouth are offered both VCT and condoms. |
| Control | No intervention | –No intervention is provided (beyond the standard available HIV prevention services within the area) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.
Key exclusion criteria (1 listed)
- Youth sampled for the study who do not consent to participate.
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 |
|---|---|---|
| Voluntary Counseling and Testing for HIV (VCT)Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP). | Behavioural | VCT and Condoms, Voluntary Counseling and Testing for HIV (VCT) |
| CondomsYouth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge. | Behavioural | Condoms, VCT and Condoms |
Primary outcome
HSV-2 prevalence
Time frame: 2 years post-intervention
Assessed via a blood test
7 secondary outcomes
% of youth who have high HIV knowledge
Time frame: 2 years post-intervention
% of youth who did not use a condom at last intercourse
Time frame: 2 years post-intervention
% of youth who reported having an STI or symptoms of an STI
Time frame: 2 years post-intervention
% of youth who report ever being pregnant
Time frame: 2 years post-intervention
Number of sexual partners
Time frame: 2 years post-intervention
HIV prevalence
Time frame: 2 years post-intervention
% of youth who have accepting attitudes towards people living with HIV (PLHIV)
Time frame: 2 years post-intervention
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 14 Jan 2020.
- Derived from this study: PubMed 31361767Duflo E, Dupas P, Ginn T, Barasa GM, Baraza M, Pouliquen V, Sharma V. HIV prevention among youth: A randomized controlled trial of voluntary counseling and testing for HIV and male condom distribution in rural Kenya. PLoS One. 2019 Jul 30;14(7):e0219535. doi: 10.1371/journal.pone.0219535. eCollection 2019.
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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.
Esther Duflo principal investigator
Massachusetts Institute of Technology
Pascaline Dupas principal investigator
Stanford University
Vandana Sharma principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary Counseling and Testing for HIV (VCT) and Condoms in people with HIV/AIDS and HSV-2 Infection, run by Abdul Latif Jameel Poverty Action Lab.
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 1 inclusion and 1 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
HSV-2 prevalence (time frame: 2 years post-intervention). 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 NCT03868644, 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 14 Jan 2020.