Improving the Reproductive Health of Families

Reproductive Health Clinical Trial

Official title:

Improving the Reproductive Health of Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858803
• Other study ID #: Botswana Study
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2020
• Source: Portland State University
• Contact: Janet S St. Lawrence
• Phone: 5034447507
• Email: jstla2[@]pdx.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.

Description:

Youth in Botswana face extraordinary challenges as they transition through adolescence. High rates of teen pregnancy force girls to drop out of school after which few resume their education. Sexually transmitted infections (STIs) are prevalent and the country has the 3rd highest Human Immunodeficiency Virus (HIV) prevalence in the world, with incidence increasing rapidly among adolescents 15-19, peaking at 40.2% HIV seroprevalence at ages 30-34. Traditional methods for sex education through village initiation schools are no longer available and parents are not comfortable with discussions addressing reproductive health within the family. As a result, adolescents have no conduit to educate them about healthy sexual development. This study will recruit 456 families, ½ with a male and ½ with a female adolescent. Families will be randomized to one of three intervention arms. Parents will participate in Families Matter 2! (FM2) and adolescents in Living as a Safer Teen (LAST), both evidence-based interventions that were adapted and pilot tested in Botswana during an earlier R34 award. In Arm 1, the parent will participate in FM2 immediately and the youth will participate in LAST six months later. In Arm 2, both the parent and youth will participant in their respective interventions simultaneously. In Arm 3, the comparison condition, participants will be offered the interventions immediately after the final assessment. Each adolescent and parent will complete assessments in English or Setswana at baseline, post-intervention, and 6- and 12-month follow-ups. Results from a pilot trial of the adapted interventions suggest that these interventions may result in improved family communications, child management skills, knowledge of sexual development, more favorable attitudes toward contraception, less tolerance for intergenerational transactional sex, greater rejection of gender violence, and lower rates of sexual risk behavior by both parents and adolescents. It is further anticipated that youths who are abstinent upon entering the intervention will delay sexual debut to a greater extent than youth in the comparison arm. This proposed study addresses the highest priority in Botswana's current national strategic plan: preventing early pregnancy, STIs and HIV in adolescents. If the proposed randomized controlled trial (RCT) provides strong evidence of effectiveness, the investigators will work with the Ministries of Education, Health, Youth & Culture and the Office of the President to disseminate the intervention throughout Botswana.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adolescent 13-18 in or near Gaborone Botswana and parent/guardian

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Reproductive Health

Intervention

Behavioral:
• Families Matter 2
Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
• Living as a Safer Teen
Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.

Locations

Country	Name	City	State
United States	Janet S. St. Lawrence	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of unprotected intercourse (youth and parents)	Self-reported frequency of unprotected intercourse occasions in past 3 months.	one year
Primary	Changes in Reproductive Health Knowledge Test scores (youth)	Measure of knowledge about prevention of STIs, HIV, and pregnancy. Total score range 0-26. No subscales. Higher scores reflect more accurate knowledge.	one year
Primary	Changes in Condom Barriers Scale(youth)	Total score range 0 - 140; Higher scores reflect fewer perceived barriers to condom use. No subscales	one year
Primary	Change in Attitudes toward Transactional Sex Scale (youth)	Total score range 0 - 120, No subscales, Higher scores reflect less acceptance of transactional sex	one year
Primary	Change in number of sex partners (youth and parent)	Change in self-reported numbers of sex partners in past three months	one year
Primary	Changes on Family Communication Scale (parents and youth)	Total scale range 0-52, No subscales, Higher scores reflect more frequent communication between parent and child frequency	One year
Primary	Changes in scores on the Condom Attitudes Scale (youth)	Total scale score range 0-144, No subscales, Higher scores reflect more positive attitudes toward condom use	One year
Primary	Changes in scores on Self Efficacy Beliefs Scale (youth)	Total scale score range 0-160, No subscales, Higher scores reflect endorsement of greater self efficacy beliefs	One year
Primary	Changes on Parental Responsiveness Scale (parent and youth)	Total scale score range 0-11, No subscales, Higher scores reflect reports of greater parental responsiveness	One year
Primary	Changes in Parent Use of Positive Reinforcement Scale (parent and youth)	Total score range 0-12, No Subscales, Higher score reflect reports of more frequent use of positive reinforcement by parents	One year
Primary	Changes in Parental Monitoring Scale (parent and youth)	Total scale score range 0-16, No subscales, Higher scores reflect report of greater parental monitoring	One year