Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)

NCT ID: NCT01571128

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-23

Brief 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 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.

Conditions

HIV; Adolescent Behavior; Gender

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Male-Specific Intervention Package

Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.

Group Type: EXPERIMENTAL

Male-Specific Intervention Package

Intervention Type: OTHER

Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Female-Specific Intervention Package

Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.

Group Type: EXPERIMENTAL

Female-Specific Intervention Package

Intervention Type: OTHER

Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

HIV Positive Cohort (Males and Females)

Behavioral data on HIV positive youth. Longitudinal Arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pre-Exposure Prophylaxis (Females)

PrEP adherence and feasibility. Longitudinal Arm.

Group Type: EXPERIMENTAL

Pre-Exposure Prophylaxis (Females)

Intervention Type: DRUG

Females 18-24 who are out of school.

Cash Transfer Cohort (Females)

School attendance, behavioral data, and feasibility. Longitudinal Arm

Group Type: EXPERIMENTAL

Cash Transfer Cohort (Females)

Intervention Type: BEHAVIORAL

Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Interventions

Male-Specific Intervention Package

Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Intervention Type: OTHER

Female-Specific Intervention Package

Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Intervention Type: OTHER

Pre-Exposure Prophylaxis (Females)

Females 18-24 who are out of school.

Intervention Type: DRUG

Cash Transfer Cohort (Females)

Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Intervention Type: BEHAVIORAL

Other Intervention Names

HIV Counseling and Testing (HTC); Facilitated linkage to care for HIV+: ART/PMTCT; Condoms; Voluntary Medical Male Circumcision (VMMC); HIV Counseling and Testing (HTC); Facilitated linkage to care for HIV+: ART/PMTCT; Contraception/Family Planning (FP); Pre-exposure Prophylaxis (PrEP); Conditional Cash Transfer (CCT); Truvada; Emtricitabine; Tenofovir disoproxil fumarate; Behavioral Economics; Conditional Cash Transfer

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nairobi

OTHER

Sponsor Role: collaborator

Impact Research & Development Organization

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Inwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kenyatta National Hospital: University of Nairobi, Kenya

Ann Kurth, PhD, CNM

Role: PRINCIPAL_INVESTIGATOR

New York University

Jasmine Buttolph, MPH

Role: STUDY_DIRECTOR

New York University

Locations

New York University

New York, New York, United States

Impact Research and Development Organization

Kisumu, , Kenya

University of Nairobi

Nairobi, , Kenya

Countries

United States; Kenya

References

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.

Reference Type: DERIVED

PMID: 28274904 (View on PubMed)

Other Identifiers

1R01AI094607

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AI094607-1

Identifier Type: -

Identifier Source: org_study_id