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

2018年1月19日 更新者:Mary Katherine Hutchinson、Boston College
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.

調査の概要

詳細な説明

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 for HIV and other sexually transmitted infections (STIs) due to a number of cultural factors (including male-dominated gender norms and older male partners) and lack of knowledge and skills related to sexual communication, refusal and HIV prevention. Reducing the sexual risk behaviors of Jamaican adolescent females is critical to reducing their risk for HIV/STIs. U.S. studies have shown that parents, particularly mothers, may act as key influences of their daughters' sexual risk beliefs and behaviors. However, no studies have documented these parental effects outside of the U.S. and no studies have evaluated the effectiveness of family-based HIV risk-reduction interventions with international populations, including Jamaican adolescents. Further, it is not yet known whether the instruments used to assess the theoretical constructs of interest are culturally sensitive or appropriate for use with Jamaican adolescents and adults. Hence, the broad objective of this proposal is to develop and test a culturally sensitive, theory-based, gender-specific Jamaican mother-daughter HIV risk-reduction intervention by using community-based participatory research methods and existing collaborative relationships between investigators from the New York University, the University of Pennsylvania Center for Health Disparities Research (PENN) and the University of the West Indies (UWI), Mona Campus. Building upon already completed preliminary elicitation research with Jamaican adolescents, parents, teachers and stakeholders, the investigative team proposes to a) conduct in-depth elicitation research into the social, cultural and family factors that influence HIV-related sexual risk behaviors among Jamaican adolescent girls; b) collaboratively develop a culturally appropriate, gender specific, theory-based mother-daughter HIV risk reduction intervention for Jamaican adolescent girls and their mothers; c) enhance the research capacity of the UWI School of Nursing and the sustainability of the intervention program; d) assess the cultural appropriateness of study instruments and adapt and refine as needed; and e) evaluate the effectiveness of the mother-daughter HIV/STI risk reduction intervention through a randomized pilot study. Although the term "mother" is used throughout the application, it is defined based upon the preliminary elicitation research already completed in Jamaica. The term "mother" will be used to represent the primary female guardian or caregiver; this may be the mother, step-mother, aunt, grandmother or other related or unrelated female guardian or caregiver. In the proposed pilot study, the plan is to recruit 360 Jamaican adolescent females, ages 13 - 17 years, and their mothers from non-governmental community-based organizations (CBOs) in and around Kingston, Jamaica and randomly assign them to either a mother-daughter HIV/STI risk-reduction intervention condition or a "no intervention" waitlist control condition that includes only a brief educational activity addressing heart disease. The HIV risk-reduction intervention will be implemented by trained adult Jamaican women (nurses and CBO staff). The adolescent component is designed to reduce HIV-related sexual risk behaviors (e.g., sexual intercourse, unprotected intercourse, multiple partners); 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. A "no intervention" waitlist control condition is being employed as the proposed project is a pilot study of the HIV/STI risk-reduction intervention. Should the pilot study find evidence of intervention effectiveness, a full RCT study with long-term follow-up and examination of moderation of intervention effects will be proposed in a subsequent application.

There are four specific aims for the proposed project. Aim 1 is to conduct broad, in-depth elicitation research using community-based participatory research (CBPR) methods in order to elucidate the social, cultural and family factors that influence Jamaican adolescent girls' sexual risk-taking during Years 01 and 02. Aim 2 is to develop a culturally appropriate, gender specific, theory-based, skill-building mother-daughter HIV/STI risk-reduction intervention during Year 02. Aim 3 is to evaluate the cultural appropriateness of our commonly used measures and research instruments using both qualitative and quantitative methods in Year 02. The remaining Aims evaluate the effectiveness of the Jamaican Mother-Daughter HIV/STI Risk-Reduction Project through a randomized pilot study. Aim 4A is to examine whether mothers in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and actual parenting behaviors (monitoring and PCSC) at 3- and 6-month follow-ups compared with mothers in the control group. Aim 4B is to examine whether adolescent girls in the HIV/STI risk-reduction intervention condition show a greater increase in intentions and reduction in actual sexual risk behaviors (sexual intercourse, unprotected intercourse, number of sexual partners) at 3- and 6-month follow-ups compared with girls in the control group. Aim 4C is to examine whether adolescents in the HIV/STI risk-reduction intervention exhibit a lower incidence of clinically documented STIs at 6-month follow-up compared with the adolescents in the control condition. Aim 4D is to identify why and how the mother-daughter HIV/STI risk-reduction intervention works (i.e., mediation of effects). The mother-daughter intervention is based on a family expansion of the Theory of Planned Behavior. The intervention is intended to affect the adolescents' sexual risk behaviors (abstinence, intercourse, unprotected intercourse, condom use, number of partners) by affecting their behavioral, normative and control beliefs and intentions toward safer sex and sexual risk behaviors. It is also designed to affect mothers' key parenting behaviors (monitoring and PTSRC) by affecting their behavioral beliefs, normative beliefs, control beliefs, and intentions toward those parenting behaviors. Parenting behaviors should, in turn, indirectly affect adolescents' sexual risk beliefs, intentions and behaviors. Thus, these theoretical mediators will be assessed in order to understand why the intervention is effective or not. Findings from this study will contribute to the development of effective HIV/STI risk-reduction programs for Jamaican adolescent girls. Significant information will also be gained regarding the design of effective family-based interventions, how to partner with international organizations and communities, and how to develop culturally appropriate instruments and effective HIV risk-reduction interventions for use with international populations at highest risk for HIV/AIDS.

研究の種類

介入

入学 (実際)

662

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

13年~17年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in adolescent girls' baseline self-reported frequency of condom use at 3 and 6 months
時間枠: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
Assessed at baseline, 3- and 6-months; reported for past 3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Adolescent girls' clinically documented STIs
時間枠:Assessed at baseline and 6-month follow-up
Urine pcr tests for chlamydia and gonorrhea
Assessed at baseline and 6-month follow-up
Change in adolescent girls' baseline self-reported condom use intentions at 3 and 6 months
時間枠: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
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
時間枠: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
Assessed at baseline and 3- and 6-month follow-up
Changes in mothers' baseline HIV knowledge scale scores at 3 and 6 months
時間枠: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
Assessed at baseline and 3- and 6-month follow-up
Change in mothers' baseline parental monitoring scale scores at 3 and 6 months
時間枠: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
Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months
Change in adolescent girls' baseline parent-teen sexual risk communication (PTSRC) scale scores at 3 and 6 months
時間枠: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
Assessed at baseline and 3- and 6-month follow-up; reported for past 3 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Mary K Hutchinson, PhD、Boston College

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2007年9月29日

一次修了 (実際)

2011年7月28日

研究の完了 (実際)

2012年6月30日

試験登録日

最初に提出

2018年1月3日

QC基準を満たした最初の提出物

2018年1月19日

最初の投稿 (実際)

2018年1月26日

学習記録の更新

投稿された最後の更新 (実際)

2018年1月26日

QC基準を満たした最後の更新が送信されました

2018年1月19日

最終確認日

2018年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • R01NR010478 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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