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临床试验/NCT07587281
NCT07587281进行中(未招募)不适用

Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements

Pacific Institute for Research and Evaluation1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2026年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
610
试验地点
1
主要终点
Self-efficacy to abstain

研究概览

简要总结

This two-year study evaluates a mobile phone-based comprehensive sexuality education program designed to support adolescent sexual and reproductive health in Kenya, where rates of teenage pregnancy and sexually transmitted infections remain high. The program, called AskDoki, delivers age-appropriate health information through the WhatsApp platform and is supported by trained youth peer leaders known as Digital Champions, who help adolescents access and use the program. Communities participating in the study are assigned either to receive the AskDoki program with Digital Champion support (intervention communities) or to not receive the program (comparison communities). Adolescents in both intervention and comparison communities complete surveys before the program begins and again six months after implementation of the AskDoki program. The surveys assess health knowledge, attitudes, perceptions, and intended behaviors related to sexual and reproductive health. The study compares changes in survey responses over time between intervention and comparison communities to assess the program's effectiveness. It also evaluates how feasible it is to use Digital Champions to support adolescents' engagement with the mobile program and examines the cost-effectiveness of this approach.

详细描述

Despite recent improvements in adolescent sexual and reproductive health outcomes in Kenya, rates of unsafe sex, unintended pregnancy, abortion, and sexually transmitted infections remain high. School based comprehensive sexuality education has been shown to improve adolescent sexual and reproductive health outcomes; however, implementation in Kenya is often limited by curriculum constraints and challenges faced by teachers, including limited time, training, and resources. As a result, many adolescents lack access to adequate sexuality education outside the formal school setting. Mobile health technology may offer a cost effective approach to delivering comprehensive sexuality education to adolescents. Amref Health Africa in Kenya developed and pilot tested a mobile, WhatsApp based artificial intelligence chatbot called AskDoki, designed to provide age appropriate comprehensive sexuality education. Preliminary findings suggested that pairing the digital curriculum with trained youth peer leaders-referred to as Digital Champions-may enhance reach, engagement, and effectiveness, particularly among adolescents with limited access to personal mobile devices. Pacific Institute for Research and Evaluation (PIRE), in collaboration with Amref Health Africa, is implementing AskDoki in urban informal settlements in Kenya using a community based approach. The study uses a quasi experimental design in which communities are assigned either to receive the AskDoki program supported by Digital Champions or to serve as comparison communities without access to the intervention. Adolescents aged 15 to 19 years complete surveys at baseline and six months after program implementation. The study evaluates changes over time in key determinants of sexual and reproductive health behaviors, including knowledge, attitudes, perceptions, self efficacy, and behavioral intentions, and compares outcomes between intervention and comparison communities. In addition, the study includes a process evaluation to assess the feasibility, acceptability, and implementation of the Digital Champion strategy. A cost effectiveness analysis is conducted to estimate the cost per adolescent reached and the cost per adolescent achieving improvements in key outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent participants
  • Inclusion criteria:
  • age 15-19
  • residing in one of the informal settlements participating in the study
  • not planning to relocate for 18 months
  • not currently married or living as married
  • comprehension of informed consent
  • willing to provide assent/consent

排除标准

  • Age 14 and younger
  • Age 20 and older
  • Married/living as married
  • Planning to relocate within 18 months
  • Not residing in one of the informal settlements participating in the study
  • Unable to comprehend informed consent
  • Unwilling to provide assent/consent.

研究组 & 干预措施

AskDoki plus Digital Champions

Experimental

Intervention communities receive access to the AskDoki WhatsApp chatbot delivering comprehensive sexuality education, with support from trained youth peer leaders ("Digital Champions") who facilitate adolescent engagement with the program.

干预措施: Chatbot providing comprehensive sexuality education plus youth peer facilitators (Combination Product)

No access to AskDoki or Digital Champions

No Intervention

Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period.

结局指标

主要结局

Self-efficacy to abstain

时间窗: Baseline and 6 months post-intervention

Change in respondents' confidence in their ability to abstain from sex. Example item: "I can refuse sex when I don't feel like having sex." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Sexual self-efficacy

时间窗: Baseline and 6 months post-intervention

Change in respondents' confidence to negotiate and use condoms. Example item: "I can negotiate condom use with a potential partner". Eight summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Perceived advantages of delaying sex

时间窗: Baseline and 6 months post-intervention

Change in respondents' perceptions about the advantages of delaying sex. Example item: "Waiting until I am older before I have sex will… Help me achieve my life's goals." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Perceived disadvantages of delaying sex

时间窗: Baseline and 6 months post-intervention

Change in respondents' perceptions about the disadvantages of delaying sex. Example item: "Waiting until I am older before I have sex will… Make me look old-fashioned." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Attitudes towards condoms

时间窗: Baseline and 6 months post-intervention

Change in respondents' perceptions about condom use. Example item: "It is OK to use condoms." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Perceived norms of delaying sex

时间窗: Baseline and 6 months post-intervention

Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning delaying sex. Example item: "Most of my friends think that I should wait until I am older before I have sex." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Subjective norms about condoms

时间窗: Baseline and 6 months post-intervention

Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning condoms. Example item: "My friends think that I should carry a condom." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).

Intention to abstain from sex

时间窗: Baseline and 6 months post-intervention

Change in respondents' intention to have sex within next month, 6 months, a year. Example item: "I intend to have sex within the next month." Three items summed and averaged. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree). Responses are inversely coded to reflect intention to abstain from sex.

Intentions to use condoms

时间窗: Baseline and 6 months post-intervention

Change in respondents' intention to use a condom during sexual intercourse. Single item: "I plan to use a condom when I have sexual intercourse." Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).

Sexual Behavior

时间窗: Baseline and 6 months post-intervention

Change in respondents' sexual behavior. Example item: "Have you had vaginal sex with anyone in the past 6 months?" (yes/no). Three items to assess any sexual activity (i.e., anal, oral, and vaginal sex).

Frequency of sexual activity

时间窗: Baseline and 6 months post-intervention

Change in how often respondents had sex in past month. Single item: "In the past month, how frequently did you have sex?" Five response options from "Zero times" to "More than four times a week."

Condom use at last sex

时间窗: Baseline and 6 months post-intervention

Condom used at last sex reported in survey. Single item: "Did you or your partner use a condom the last time your had sex?" (yes/no).

Condom use consistency

时间窗: Baseline and 6 months post-intervention

Condom use frequency reported in survey. Single item: "In the past month, how frequently did you use a condom when having sex?" Five response options ("Never, none of the time" to "Always, every time").

次要结局

  • Knowledge about sexual and reproductive health(Baseline and 6 months post-intervention)
  • Self-reported STI symptoms(Baseline and 6 months post-intervention)
  • Self-reported history of adolescent pregnancies(Baseline and 6 months post-intervention)
  • Retention of Digital Champions(Start-up of intervention through six-month intervention period)
  • Intention to test and treat STIs(Baseline and 6 months post-intervention)
  • Intention to use SRH services(Baseline and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Winfred K. Luseno

Senior Research Scientist

Pacific Institute for Research and Evaluation

研究点 (1)

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