Clinical trial NCT03858803: Improving the Reproductive Health of Families
Official title: Improving the Reproductive Health of Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reproductive Health
Keywords: HIV
STI
Unplanned pregnancy
Reproductive health of families
Adolescents
Lead sponsor: Portland State University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Random assignment to one of three experimental arms:

Arm 1: Parents complete intervention immediately, adolescents complete intervention 6 month later Arm 2: Both parents and adolescents participate in intervention simultaneously Arm 3: Comparison condition in which both parents and adolescents are offered their respective interventions after the final assessment
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in frequency of unprotected intercourse (youth and parents)
timeFrame: one year
measure: Changes in Reproductive Health Knowledge Test scores (youth)
timeFrame: one year
measure: Changes in Condom Barriers Scale(youth)
timeFrame: one year
measure: Change in Attitudes toward Transactional Sex Scale (youth)
timeFrame: one year
measure: Change in number of sex partners (youth and parent)
timeFrame: one year
measure: Changes on Family Communication Scale (parents and youth)
timeFrame: One year
measure: Changes in scores on the Condom Attitudes Scale (youth)
timeFrame: One year
measure: Changes in scores on Self Efficacy Beliefs Scale (youth)
timeFrame: One year
measure: Changes on Parental Responsiveness Scale (parent and youth)
timeFrame: One year
measure: Changes in Parent Use of Positive Reinforcement Scale (parent and youth)
timeFrame: One year
measure: Changes in Parental Monitoring Scale (parent and youth)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Janet S. St. Lawrence
state: Oregon
Study officials:
affiliation: Portland State University
name: Janet S St. Lawrence, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Botswana
name: Esther S Seloilwe, Ph.D.
role: STUDY_DIRECTOR
References: