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

New York University (NYU)

Status: Completed

Conditions: HIV; Gender; Adolescent Behavior

Treatments: Other: Female-Specific Intervention Package; Behavioral: Cash Transfer Cohort (Females); Drug: Pre-Exposure Prophylaxis (Females); Other: Male-Specific Intervention Package

Study type: Interventional

Funder types: Other

Identifiers

NCT01571128

1R01AI094607 (U.S. NIH Grant/Contract)

1R01AI094607-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,215 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,215 participants in 5 patient groups

Male-Specific Intervention Package

Experimental group

Description:

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

Treatment:

Other: Male-Specific Intervention Package

Female-Specific Intervention Package

Experimental group

Description:

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

Treatment:

Other: Female-Specific Intervention Package

HIV Positive Cohort (Males and Females)

No Intervention group

Description:

Behavioral data on HIV positive youth. Longitudinal Arm.

Pre-Exposure Prophylaxis (Females)

Experimental group

Description:

PrEP adherence and feasibility. Longitudinal Arm.

Treatment:

Drug: Pre-Exposure Prophylaxis (Females)

Cash Transfer Cohort (Females)

Experimental group

Description:

School attendance, behavioral data, and feasibility. Longitudinal Arm

Treatment:

Behavioral: Cash Transfer Cohort (Females)