Clinical trial NCT02888678: Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa
Official title: A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
HIV Infections
Keywords: ASPIRES
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Foundation for Professional Development
name: Future Families
First posted: 2016-09-05
Enrollment: 1773
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Detailed description: In South Africa, the overall HIV prevalence of 12.2% can be reviewed based on a number of factors: age, province, type of locality, race, economic household conditions, and marital status. Those to be reached through the ASPIRES intervention and evaluation are economically disadvantaged Black African youth, male and female, located in urban localities in Gauteng province, and are situated within a setting of high risk and vulnerability for HIV. The ASPIRES project is providing technical assistance to provide economic strengthening (ES) and HIV prevention education programming for adolescents. The ASPIRES ES intervention includes financial capability building through the provision of financial education in combination with access to appropriate youth-friendly savings mechanisms. The HIV prevention education intervention Vhutshilo 2.2 will be used in this study.

This study will assess whether the integration of an ES intervention with an HIV-prevention education intervention improves economic and health outcomes beyond singular interventions, estimate the resources required at the program level to support the ES and HIV-prevention education interventions; and describe whether the interventions were perceived as effective in addressing economic and health outcomes and to describe how and why the interventions were perceived as effective or not.

This study will enroll up to 2000 youth ages 14-17 and randomly assign them to either 1) ES intervention only, 2) HIV prevention intervention only, 3) combined ES and HIV intervention, or 4) no intervention.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: STI prevalence Endline 1
timeFrame: Nine months after baseline interview
measure: STI prevalence Endline 2
timeFrame: eighteen months after baseline interview
Secondary outcomes:
measure: Prevalence of pregnancy Endline 1
timeFrame: Nine months after baseline interview
measure: Prevalence of pregnancy Endline 2
timeFrame: eighteen months after baseline interview
measure: Percent of adolescents engaging in protective sexual behavior Endline 1
timeFrame: In the 6 month time period prior to the date of the follow up visit
measure: Percent of adolescents engaging in protective sexual behavior Endline 2
timeFrame: In the 6 month time period prior to the date of the follow up visit
measure: Percent of adolescents engaging in transactional sex in past 6 months Endline 1
timeFrame: In the 6 months prior to the date of the follow up visit
measure: Percent of adolescents engaging in transactional sex in past 6 months Endline 2
timeFrame: In the 6 months prior to the date of the follow up visit
measure: Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1
timeFrame: In the 6 months prior to the date of the follow up visit
measure: Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2
timeFrame: In the 6 months prior to the date of the follow up visit
measure: Mean HIV knowledge score Endline 1
timeFrame: Nine months after baseline interview
measure: Mean HIV knowledge score Endline 2
timeFrame: Eighteen months after baseline interview
measure: Mean financial literacy score Endline 1
timeFrame: Nine months after baseline interview
measure: Mean financial literacy score Endline 2
timeFrame: eighteen months after baseline interview
measure: Percent of adolescents participating in savings group Endline 1
timeFrame: Nine months after baseline interview
measure: Percent of adolescents participating in savings group Endline 2
timeFrame: eighteen months after baseline interview
measure: Percent of adolescents opening savings account Endline 1
timeFrame: Nine months after baseline interview
measure: Percent of adolescents opening savings account Endline 2
timeFrame: eighteen months after baseline interview
measure: Mean total amount of savings in past 1 year Endline 1
timeFrame: In the one year prior to the date of the 9 month follow up visit
measure: Mean total amount of savings in past 1 year Endline 2
timeFrame: In the one year prior to the date of the 18 month follow up visit
measure: Percent of adolescents saving for education Endline 1
timeFrame: Nine months after baseline interview
measure: Percent of adolescents saving for education Endline 2
timeFrame: eighteen months after baseline interview
measure: Percent of adolescents whose caregiver provided money for savings Endline 1
timeFrame: Nine months after baseline interview
measure: Percent of adolescents whose caregiver provided money for savings Endline 2
timeFrame: eighteen months after baseline interview
measure: Percent of adolescents who participate in household budgeting Endline 1
timeFrame: Nine months after baseline interview
measure: Percent of adolescents who participate in household budgeting Endline 2
timeFrame: eighteen months after baseline interview
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: community Based Recruitment
state: Gauteng
Study officials:
affiliation: FHI 360
name: Holly Burke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.