NCT03411577

Brief Summary

Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan Africa. Jamaican young women and adolescent girls are at particularly high risk due to a number of cultural factors, gender norms, partnering with older male partners, and lack of knowledge and skills related to sexual refusal and HIV prevention. U.S. studies have shown that mothers may act as a key influence of their daughters' sexual risk beliefs and behaviors. However, no such studies have documented these effects outside of the U.S. and no studies have evaluated HIV risk-reduction interventions with Jamaican adolescent girls and their mothers. Hence, the purpose of this study is to partner with the University of the West Indies, Jamaican community based organizations (CBOs) and families in order to develop and test a culture-specific mother-daughter HIV risk-reduction intervention in a randomized field experiment. Specifically, the investigative team will evaluate whether a culture-specific, theory-based, skill-building intervention with Jamaican adolescent girls and their mothers can directly and/or indirectly reduce these girls' HIV risk-associated sexual behaviors. Jamaican girls, ages 13 - 17, and their mothers/female guardians will be recruited from CBOs and randomly assigned to either: (a) a mother-daughter HIV risk-reduction intervention condition or (b) a "no intervention" waitlist control condition. The HIV risk-reduction intervention includes 12 1-hour modules scheduled over 2 days and implemented by trained adult Jamaican women (nurses and CBO staff). The mother component is designed to increase those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication \[PTSRC\]) associated with reduced adolescent sexual risk-taking; the teen component is designed to improve girls' beliefs and skills related to abstinence, sexual negotiation and condom use. A "waitlist" control condition is being employed as the proposed project is a pilot study of the HIV risk-reduction intervention. Primary outcomes include mothers'/daughters' reports of parenting behaviors (monitoring and PTSRC) and daughters' self-reports of sexual risk behaviors (sexual intercourse, unprotected sex, condom use, number of partners). Secondary outcomes include daughters' STI rates, mothers' beliefs regarding parenting behaviors and daughters beliefs regarding sexual risk behaviors.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2012

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

January 3, 2018

Last Update Submit

January 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months

    Questionnaire - self-reported single item asking frequency of condom use during past 3 months; scores range from 1 - 5; higher scores indicate greater frequency of condom use

    Assessed at baseline, 3- and 6-months; reported for past 3 months

Secondary Outcomes (6)

  • Adolescent girls' clinically documented STIs

    Assessed at baseline and 6-month follow-up

  • Change in adolescent girls' baseline self-reported condom use intentions at 3 and 6 months

    Assessed at baseline, 3- and 6-months; reported for next 3 months

  • Change in adolescent girls' baseline HIV knowledge scale scores at 3 and 6 months

    Assessed at baseline and 3- and 6-month follow-up

  • Changes in mothers' baseline HIV knowledge scale scores at 3 and 6 months

    Assessed at baseline and 3- and 6-month follow-up

  • Change in mothers' baseline parental monitoring scale scores at 3 and 6 months

    Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months

  • +1 more secondary outcomes

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

The adolescent HIV/STI risk-reduction intervention aims to: (a) increase knowledge of HIV risk and prevention; (b) strengthen behavioral beliefs regarding abstinence and safer sex; (c) increase self-efficacy and intentions to avoid unsafe sex; and (d) increase sexual communication and refusal skills. The mother component includes much of the same prevention knowledge and addresses parent-teen sexual risk communication, monitoring, and sexual role modeling. Interventions are held on two consecutive Saturdays for 6 hours each day. Mothers' groups meet separately from daughters' groups, although the groups will come together for the last module of each day.

Other: Behavioral Intervention

Control Group

NO INTERVENTION

The control / comparison group is essentially a "no intervention / wait-list" control group. However, during pilot testing, participants expressed a strong desire to engage in some type of health activity. As a result, the control group members, both mothers and daughters, participated in a brief educational activity on reducing risk for cardiovascular disease. The educational activity was limited to a few hours on one Saturday. Participants returned the following week to complete post-test questionnaires along with the participants in the experimental group.

Interventions

Behavioral Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age between 13- to 17-years, inclusive
  • resident of one of the three parishes in and around Kingston, Jamaica (the study area)
  • plan to reside in the "study area" for the next 12 months
  • able to read, write and understand English
  • unmarried and
  • agrees to participate and
  • mother or primary female guardian also agrees to participate.
  • age greater than 18
  • resident of one of the three parishes in and around Kingston, Jamaica (the study area)
  • plan to reside in the "study area" for the next 12 months
  • able to read, write and understand English and
  • agrees to participate

You may not qualify if:

  • adolescent and/or mother who is/are disruptive and/or otherwise unable to participate in small group intervention activities
  • adolescent who is married

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hutchinson MK, Smith TK, Waldron N, Kahwa E, Hewitt HH, Hamilton PI, Kang SY. Validation of the Jamaican Maternal Sexual Role Modelling Questionnaire. West Indian Med J. 2012 Dec;61(9):897-902. doi: 10.7727/wimj.2011.198.

    PMID: 24020230BACKGROUND
  • Waldron, N., Hutchinson, M.K., Hewitt, H., Kahwa, E., & Hamilton, P. (2012). Cross-cultural psychometric assessment of the parent-teen sexual risk communication scale in Jamaica. Open Journal of Preventive Medicine, 2(2), 205-213

    BACKGROUND
  • Hutchinson MK, Wood EB. Reconceptualizing adolescent sexual risk in a parent-based expansion of the Theory of Planned Behavior. J Nurs Scholarsh. 2007;39(2):141-6. doi: 10.1111/j.1547-5069.2007.00159.x.

    PMID: 17535314BACKGROUND
  • Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.

    BACKGROUND
  • Hutchinson MK. The Parent-Teen Sexual Risk Communication Scale (PTSRC-III): instrument development and psychometrics. Nurs Res. 2007 Jan-Feb;56(1):1-8. doi: 10.1097/00006199-200701000-00001.

    PMID: 17179868BACKGROUND
  • Hutchinson MK, Jemmott LS, Wood EB, Hewitt H, Kahwa E, Waldron N, Bonaparte B. Culture-specific factors contributing to HIV risk among Jamaican adolescents. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):35-47. doi: 10.1016/j.jana.2007.01.008.

  • Kang SY, Hutchinson MK, Waldron N. Characteristics related to sexual experience and condom use among Jamaican female adolescents. J Health Care Poor Underserved. 2013 Feb;24(1):220-32. doi: 10.1353/hpu.2013.0023.

  • Hutchinson MK, Kahwa E, Waldron N, Hepburn Brown C, Hamilton PI, Hewitt HH, Aiken J, Cederbaum J, Alter E, Sweet Jemmott L. Jamaican mothers' influences of adolescent girls' sexual beliefs and behaviors. J Nurs Scholarsh. 2012 Mar;44(1):27-35. doi: 10.1111/j.1547-5069.2011.01431.x. Epub 2012 Feb 16.

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mary K Hutchinson, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data collectors were unaware of group assignment of participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Mother-daughter dyads were randomly assigned to either HIV risk-reduction intervention group or control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 26, 2018

Study Start

September 29, 2007

Primary Completion

July 28, 2011

Study Completion

June 30, 2012

Last Updated

January 26, 2018

Record last verified: 2018-01