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Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03411577
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
University of the West Indies, Mona Campus, Kingston, Jamaica
University of Pennsylvania
New York University
Information provided by (Responsible Party):
Mary Katherine Hutchinson, Boston College

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.

Condition or disease Intervention/treatment Phase
Parent-Child Relations HIV Prevention Adolescent Behavior Other: Behavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 662 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mother-daughter dyads were randomly assigned to either HIV risk-reduction intervention group or control group
Masking: Single (Outcomes Assessor)
Masking Description: Data collectors were unaware of group assignment of participants.
Primary Purpose: Prevention
Official Title: Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
Actual Study Start Date : September 29, 2007
Actual Primary Completion Date : July 28, 2011
Actual Study Completion Date : June 30, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Behavioral Intervention
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
No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months [ Time Frame: Assessed at baseline, 3- and 6-months; reported for past 3 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


Secondary Outcome Measures :
  1. Adolescent girls' clinically documented STIs [ Time Frame: Assessed at baseline and 6-month follow-up ]
    Urine pcr tests for chlamydia and gonorrhea

  2. Change in adolescent girls' baseline self-reported condom use intentions at 3 and 6 months [ Time Frame: Assessed at baseline, 3- and 6-months; reported for next 3 months ]
    Questionnaire - self-reported single item asking intentions to use condoms during next 3 months; scores range from 1 to 5; higher scores indicate greater intentions

  3. Change in adolescent girls' baseline HIV knowledge scale scores at 3 and 6 months [ Time Frame: Assessed at baseline and 3- and 6-month follow-up ]
    Questionnaire - HIV/AIDS Knowledge Scale - 19 items; scores range from 0 - 19 with higher scores indicating greater amounts of knowledge

  4. Changes in mothers' baseline HIV knowledge scale scores at 3 and 6 months [ Time Frame: Assessed at baseline and 3- and 6-month follow-up ]
    Questionnaire - HIV/AIDS Knowledge Scale - 19 items; scores range from 0 - 19 with higher scores indicating greater amounts of knowledge

  5. Change in mothers' baseline parental monitoring scale scores at 3 and 6 months [ Time Frame: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months ]
    Questionnaire - self-reported 10-item scale of parental monitoring reported by daughters ; total scores range from 10 - 50; higher scores indicate more parental monitoring/supervision

  6. Change in adolescent girls' baseline parent-teen sexual risk communication (PTSRC) scale scores at 3 and 6 months [ Time Frame: Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months ]
    Questionnaire - PTSRC-III scale; 8 items; total scores range from 5 - 40; higher scores indicate greater sexual communication



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for the adolescent include:

  • 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.

Inclusion criteria for the mother/female guardian include:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411577


Sponsors and Collaborators
Boston College
University of the West Indies, Mona Campus, Kingston, Jamaica
University of Pennsylvania
New York University
Investigators
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Principal Investigator: Mary K Hutchinson, PhD Boston College
Publications of Results:
Other Publications:
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
Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.

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Responsible Party: Mary Katherine Hutchinson, Professor, Boston College
ClinicalTrials.gov Identifier: NCT03411577    
Other Study ID Numbers: R01NR010478 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decisions regarding data sharing will be made on a case-by-case basis. Those who would like to request data should contact the principal investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No