HIVMP3-YouthNCT01571128
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
A study testing Male-Specific Intervention Package, Female-Specific Intervention Package and Pre-Exposure Prophylaxis (Females) in people with HIV and Adolescent Behavior, run by New York University at 3 sites in 2 countries.
Trial summary
MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings. The study aims to pilot a combination package of gender-specific interventions in western Kenya in a mobile health delivery format using… Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Adolescent Behavior, Gender
- What is being tested?
- Male-Specific Intervention Package, Female-Specific Intervention Package and Pre-Exposure Prophylaxis (Females)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,215 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2014to 23 Mar 2016
- 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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any male or female between the ages of 15-24.
- Able to understand spoken English or Kiswahili or Dholuo.
- Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent
- Willing to be tested for HIV.
- Willing to get participant ID based on biometric finger scan.
Who cannot join
- Any male or female younger than 15 or older than 24.
- Unable to understand spoken English, or Kiswahili or Dholuo.
- If under 18 and not an emancipated minor, unable to get parental consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Kenya2 sites
Impact Research and Development Organization
Kisumu
University of Nairobi
Nairobi
About this study
MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings. The study aims to pilot a combination package of gender-specific interventions in western Kenya in a mobile health delivery format using integrated services delivery.
Read the detailed description
The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings. Our team of biobehavioral and clinical scientists, mathematical modelers, and trial design specialists will:
Aim 1: Identify gender (sex)-specific drivers of HIV acquisition risk, including pregnancy among females, for youth in sub-Saharan Africa, and interventions to best address those risks.
Aim 2: Conduct mathematical modeling to select optimal combination intervention package components and to assess potential population-level impact.
Aim 3: In partnership with a highly-productive nongovernmental organization (NGO) that is delivering PEPFAR-funded HIV prevention services, develop and pilot a combination HIV prevention package specific for female and for male youth - 'MP3-Youth' - in Nyanza Province, Kenya.
Aim 4: Design a phase IV study protocol for testing the effectiveness of a gender-specific youth HIV prevention package in sub-Saharan Africa. We will disseminate these research protocol recommendations, and study instruments including the mathematical modeling tool, as a combination prevention intervention research toolkit.
Design: Study activities comprise systematic review and meta-analysis of the HIV prevention literature for youth in sub-Saharan Africa; development of a mathematical modeling tool; and a community-based HIV combination prevention pilot that will take place in western Kenya. These activities will culminate in a testable combination HIV prevention trial protocol for youth, which is the main study deliverable.
Population: Aim 1: Focus groups will be held with male and female youth, parents, teachers, religious and community leaders. Aim 3: Pilot study will include male and female youths (ages 15-24) from Nyanza Province, Kenya.
Deliverables: Study deliverables include selection procedures for a population-specific combination HIV prevention package; measurement instruments, mobile prevention delivery protocols, mathematical modeling tools, and a testable study trial protocol. The entire MP3-Youth Package will be placed on a web site for open access.
- Conditions
- HIV, Adolescent Behavior, Gender
- Being tested
- Male-Specific Intervention Package, Female-Specific Intervention Package, Pre-Exposure Prophylaxis (Females), Cash Transfer Cohort (Females)
- Keywords
- HIV, Prevention & Control, Intervention Studies, Adolescent, Gender, Combination prevention, Pre-Exposure Prophylaxis, Cash Transfer, Medical Male Circumcision, HIV Testing, Mobile Health
- Medical subject headings
- Adolescent Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male-Specific Intervention PackageOther
Also called HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Condoms, Voluntary Medical Male Circumcision (VMMC)
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
Female-Specific Intervention PackageOther
Also called HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Contraception/Family Planning (FP), Pre-exposure Prophylaxis (PrEP)
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
Pre-Exposure Prophylaxis (Females)Drug
Also called Truvada, Emtricitabine, Tenofovir disoproxil fumarate
Females 18-24 who are out of school.
Cash Transfer Cohort (Females)Behavioural
Also called Behavioral Economics, Conditional Cash Transfer
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
| Study group | Role | What they receive |
|---|---|---|
| Male-Specific Intervention Package | Experimental | Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm. Receives: Other: Male-Specific Intervention Package |
| Female-Specific Intervention Package | Experimental | Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm. Receives: Other: Female-Specific Intervention Package |
| HIV Positive Cohort (Males and Females) | No intervention | Behavioral data on HIV positive youth. Longitudinal Arm. |
| Pre-Exposure Prophylaxis (Females) | Experimental | PrEP adherence and feasibility. Longitudinal Arm. Receives: Drug: Pre-Exposure Prophylaxis (Females) |
| Cash Transfer Cohort (Females) | Experimental | School attendance, behavioral data, and feasibility. Longitudinal Arm Receives: Behavioral: Cash Transfer Cohort (Females) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Uptake (acceptability) and Coverage (feasibility)
- Coverage: The proportion of youth in the community who attend each mobile event (estimated from youth population denominator)
- Enrollment: The number of participants who consent to being enrolled in the study during each mobile event.
- Uptake: The number of participants who choose one or more components of their tailored combination package (and which components).
- Intervention Acceptability: Satisfaction with mobile event services
Measured: 6 months
Secondary outcomes (1)
Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
- Adherence to once daily Truvada (PrEP) among HIV-uninfected eligible females and patterns of adherence and sexual HIV acquisition risk exposure (PrEP cohort participants only). Measured by self-report, eCAPs, and clinical assessments; monthly for first 6 months and every 3 months for the following 6 months and DBS for analysis of TFV/FTC: TFV-DP/FTC-TP at months 2 and 9.
- Adherence to ART for positives (HIV+ cohort participants only). Measured by self-report monthly SMS: 0, 3, 6,9,12 months). POC CD4 and baseline viral load by dried blood spot will be measured at mobile event baseline and repeated at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startNov 2014
- Primary completion23 Mar 2016
- Study completion23 Mar 2016
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 HIVStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, Impact Research & Development Organization
- Responsible party
- Sponsor
- Investigators
- Irene Inwani, MD, MPH, Principal investigator, Kenyatta National Hospital: University of Nairobi, KenyaAnn Kurth, PhD, CNM, Principal investigator, New York UniversityJasmine Buttolph, MPH, Study director, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571128
- Sponsor's protocol ID
- 1R01AI094607-1
- Other IDs
- 1R01AI094607
- Acronym
- MP3-Youth
- Status last verified
- Sep 2018
- First submitted
- 8 Feb 2012
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buttolph J, Inwani I, Agot K, Cleland CM, Cherutich P, Kiarie JN, Osoti A, Celum CL, Baeten JM, Nduati R, Kinuthia J, Hallett TB, Alsallaq R, Kurth AE. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol. JMIR Res Protoc. 2017 Mar 8;6(3):e22. doi: 10.2196/resprot.5833.
PubMed 28274904
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
- ClinicalTrials.gov ID
- NCT01571128
- Acronym / sponsor ID
- MP3-Youth / 1R01AI094607-1
- Conditions
- HIV, Adolescent Behavior, Gender
- Keywords
- HIV, Prevention & Control, Intervention Studies, Adolescent, Gender, Combination prevention, Pre-Exposure Prophylaxis, Cash Transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- University of Nairobi, Impact Research & Development Organization
- Study start
- Nov 2014 (actual)
- Primary completion
- 23 Mar 2016 (actual)
- Study completion
- 23 Mar 2016 (actual)
- First posted
- 5 Apr 2012 (estimated)
- 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.
MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings. The study aims to pilot a combination package of gender-specific interventions in western Kenya in a mobile health delivery format using integrated services delivery.
Detailed description
The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings. Our team of biobehavioral and clinical scientists, mathematical modelers, and trial design specialists will:
Aim 1: Identify gender (sex)-specific drivers of HIV acquisition risk, including pregnancy among females, for youth in sub-Saharan Africa, and interventions to best address those risks.
Aim 2: Conduct mathematical modeling to select optimal combination intervention package components and to assess potential population-level impact.
Aim 3: In partnership with a highly-productive nongovernmental organization (NGO) that is delivering PEPFAR-funded HIV prevention services, develop and pilot a combination HIV prevention package specific for female and for male youth - 'MP3-Youth' - in Nyanza Province, Kenya.
Aim 4: Design a phase IV study protocol for testing the effectiveness of a gender-specific youth HIV prevention package in sub-Saharan Africa. We will disseminate these research protocol recommendations, and study instruments including the mathematical modeling tool, as a combination prevention intervention research toolkit.
Design: Study activities comprise systematic review and meta-analysis of the HIV prevention literature for youth in sub-Saharan Africa; development of a mathematical modeling tool; and a community-based HIV combination prevention pilot that will take place in western Kenya. These activities will culminate in a testable combination HIV prevention trial protocol for youth, which is the main study deliverable.
Population: Aim 1: Focus groups will be held with male and female youth, parents, teachers, religious and community leaders. Aim 3: Pilot study will include male and female youths (ages 15-24) from Nyanza Province, Kenya.
Deliverables: Study deliverables include selection procedures for a population-specific combination HIV prevention package; measurement instruments, mobile prevention delivery protocols, mathematical modeling tools, and a testable study trial protocol. The entire MP3-Youth Package will be placed on a web site for open access.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Male-Specific Intervention Package | Experimental | Other: Male-Specific Intervention PackageGender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm. |
| Female-Specific Intervention Package | Experimental | Other: Female-Specific Intervention PackageGender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm. |
| HIV Positive Cohort (Males and Females) | No intervention | –Behavioral data on HIV positive youth. Longitudinal Arm. |
| Pre-Exposure Prophylaxis (Females) | Experimental | Drug: Pre-Exposure Prophylaxis (Females)PrEP adherence and feasibility. Longitudinal Arm. |
| Cash Transfer Cohort (Females) | Experimental | Behavioral: Cash Transfer Cohort (Females)School attendance, behavioral data, and feasibility. Longitudinal Arm |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Any male or female between the ages of 15-24.
- Able to understand spoken English or Kiswahili or Dholuo.
- Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent
- Willing to be tested for HIV.
- Willing to get participant ID based on biometric finger scan.
Key exclusion criteria (3 listed)
- Any male or female younger than 15 or older than 24.
- Unable to understand spoken English, or Kiswahili or Dholuo.
- If under 18 and not an emancipated minor, unable to get parental consent.
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 |
|---|---|---|
| Male-Specific Intervention PackageAlso: HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Condoms, Voluntary Medical Male Circumcision (VMMC)Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts. | Other | Male-Specific Intervention Package |
| Female-Specific Intervention PackageAlso: HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Contraception/Family Planning (FP), Pre-exposure Prophylaxis (PrEP)Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts. | Other | Female-Specific Intervention Package |
| Pre-Exposure Prophylaxis (Females)Also: Truvada, Emtricitabine, Tenofovir disoproxil fumarateFemales 18-24 who are out of school. | Drug | Pre-Exposure Prophylaxis (Females) |
| Cash Transfer Cohort (Females)Also: Behavioral Economics, Conditional Cash TransferCash transfer for females (and their parents) who are aged 15-24 and enrolled in school. | Behavioural | Cash Transfer Cohort (Females) |
Primary outcome
Intervention Uptake (acceptability) and Coverage (feasibility)
Time frame: 6 months
* Coverage: The proportion of youth in the community who attend each mobile event (estimated from youth population denominator) * Enrollment: The number of participants who consent to being enrolled in the study during each mobile event. * Uptake: The number of participants who choose one or more components of their tailored combination package (and which components). * Intervention Acceptability: Satisfaction with mobile event services
1 secondary outcome
Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
Time frame: 12 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 18 Feb 2022.
- Derived from this study: PubMed 28274904Buttolph J, Inwani I, Agot K, Cleland CM, Cherutich P, Kiarie JN, Osoti A, Celum CL, Baeten JM, Nduati R, Kinuthia J, Hallett TB, Alsallaq R, Kurth AE. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol. JMIR Res Protoc. 2017 Mar 8;6(3):e22. doi: 10.2196/resprot.5833.
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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.
Irene Inwani, MD, MPH principal investigator
Kenyatta National Hospital: University of Nairobi, Kenya
Ann Kurth, PhD, CNM principal investigator
New York University
Jasmine Buttolph, MPH study director
New York University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male-Specific Intervention Package, Female-Specific Intervention Package and Pre-Exposure Prophylaxis (Females) in people with HIV and Adolescent Behavior, run by New York University at 3 sites in 2 countries.
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 5 inclusion and 3 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya, United States. 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?
Intervention Uptake (acceptability) and Coverage (feasibility) (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 NCT01571128, 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 18 Feb 2022.