Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa

NCT02888678 | Completed

• 1 other identifier: 741818
• Study Type: interventional
• Target: 1,773
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether the integration of an Economic Strengthening program with an HIV-prevention education program produce synergistic effects on economic and health outcomes for South African youth ages 14-17 years old.

Conditions

HIV; HIV Infections

Keywords

ASPIRES

Outcome Measures

Primary Outcomes (2)

• STI prevalence Endline 1

  Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)

  Nine months after baseline interview

• STI prevalence Endline 2

  Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)

  eighteen months after baseline interview

Secondary Outcomes (24)

• Prevalence of pregnancy Endline 1

  Nine months after baseline interview

• Prevalence of pregnancy Endline 2

  eighteen months after baseline interview

• Percent of adolescents engaging in protective sexual behavior Endline 1

  In the 6 month time period prior to the date of the follow up visit

• Percent of adolescents engaging in protective sexual behavior Endline 2

  In the 6 month time period prior to the date of the follow up visit

• Percent of adolescents engaging in transactional sex in past 6 months Endline 1

  In the 6 months prior to the date of the follow up visit

Study Arms (4)

ES + HIV Prevention

EXPERIMENTAL

Economic Strengthening + HIV prevention education combined intervention consists of 2 parts. Impumelelo: This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms. Vhutshilo 2.2: . This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

Behavioral: Economic Strengthening (Impumelelo); Behavioral: HIV Prevention Education (Vhutshilo 2.2)

ES only

EXPERIMENTAL

Economic Strengthening (Impumelelo): This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.

Behavioral: Economic Strengthening (Impumelelo)

HIV only

EXPERIMENTAL

HIV Prevention Education (Vhutshilo 2.2): This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

Behavioral: HIV Prevention Education (Vhutshilo 2.2)

No intervention (control)

NO INTERVENTION

The control group will not receive the ES or HIV prevention interventions. They will receive the basic package of services available to all beneficiaries of Future Families.

Interventions

Economic Strengthening (Impumelelo) BEHAVIORAL

Economic Strengthening (Impumelelo): This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.

ES + HIV Prevention; ES only

HIV Prevention Education (Vhutshilo 2.2) BEHAVIORAL

HIV Prevention Education (Vhutshilo 2.2): This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

ES + HIV Prevention; HIV only

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Beneficiary of Future Families in a study community
• Parent or guardian consent allowing adolescent to participate in the study
• Willing to sign or make their mark on an assent form
• Willing to provide contact information
• Only one adolescent is eligible per household

Sponsors & Collaborators

• FHI 360: lead
• Foundation for Professional Development: collaborator
• Future Families: collaborator

Study Sites (1)

community Based Recruitment

Pretoria, Gauteng, South Africa

Location

Related Publications (1)

• Burke HM, Chen M, Murray K, Bezuidenhout C, Ngwepe P, Bernholc A, Medina-Marino A. The effects of the integration of an economic strengthening and HIV prevention education programme on the prevalence of sexually transmitted infections and savings behaviours among adolescents: a full-factorial randomised controlled trial in South Africa. BMJ Glob Health. 2020 Apr 7;5(4):e002029. doi: 10.1136/bmjgh-2019-002029. eCollection 2020.

  PMID: 32355569 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Holly Burke, PhD

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: September 5, 2016
• Study Start: February 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)