Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
2026年9月14日 更新者：Winfred K. Luseno、Pacific Institute for Research and Evaluation
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.
研究概览
地位
主动，不招人
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
610
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Nairobi、肯尼亚
- Amref Health Africa in Kenya
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
是的
描述
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
Exclusion criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AskDoki plus Digital Champions
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.
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A chatbot designed to provide comprehensive sexuality education (named "AskDoki") to adolescents is deployed in a community targeted to receive the intervention along with peer facilitators.
The facilitators are young adults (named "Digital Champions") who are trained to promote and facilitate access and use among adolescents of a chatbot.
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无干预：No access to AskDoki or Digital Champions
Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-efficacy to abstain
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Sexual self-efficacy
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Perceived advantages of delaying sex
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Perceived disadvantages of delaying sex
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Attitudes towards condoms
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Perceived norms of delaying sex
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Subjective norms about condoms
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Intention to abstain from sex
大体时间：Baseline and 6 months post-intervention
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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. |
Baseline and 6 months post-intervention
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Intentions to use condoms
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Sexual Behavior
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Frequency of sexual activity
大体时间：Baseline and 6 months post-intervention
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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."
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Baseline and 6 months post-intervention
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Condom use at last sex
大体时间：Baseline and 6 months post-intervention
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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).
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Baseline and 6 months post-intervention
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Condom use consistency
大体时间：Baseline and 6 months post-intervention
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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").
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Baseline and 6 months post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knowledge about sexual and reproductive health
大体时间：Baseline and 6 months post-intervention
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Measures change in knowledge about sexually transmitted infections (STIs), sexual behavior, and pregnancy.
Example item: "Can a person who looks strong and healthy be HIV positive?"
(yes/no) Items will be summed and averaged.
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Baseline and 6 months post-intervention
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Self-reported STI symptoms
大体时间：Baseline and 6 months post-intervention
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Respondents' self-reported STI symptoms.
Example item: "Do you currently have any of the following symptoms?... Sore or lesions in your genital area or anus" (yes/no).
Six items will be used to derive prevalence and distribution of STI symptoms.
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Baseline and 6 months post-intervention
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Self-reported history of adolescent pregnancies
大体时间：Baseline and 6 months post-intervention
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Respondents' self-reported history of pregnancy and impregnating someone.
Example item: "Are you or your partner currently pregnant?""
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Baseline and 6 months post-intervention
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Intention to test and treat STIs
大体时间：Baseline and 6 months post-intervention
|
Two survey items assessing intentions to test and treat STIs.
Example item: "I plan to visit a clinic to test for STIs if I have symptoms."
Two summed items.
Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).
Items were newly created for this study.
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Baseline and 6 months post-intervention
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Intention to use SRH services
大体时间：Baseline and 6 months post-intervention
|
Increase in intention to use SRH services.
Single item: "I plan to visit a clinic for family planning services."
Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).
Item was newly created for this study.
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Baseline and 6 months post-intervention
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Retention of Digital Champions
大体时间：Start-up of intervention through six-month intervention period
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Percent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.
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Start-up of intervention through six-month intervention period
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
大体时间：Immediately post-intervention
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Average of 6 items about acceptability on post intervention survey.
Example item: "Overall, how acceptable did you find the Digital Champions?"
Response options are on a 5-point Likert scale.
Items were adapted from a questionnaire based on the Theoretical Framework of Acceptability.
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Immediately post-intervention
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Cost per adolescent served.
大体时间：Start-up of intervention through six-month intervention period
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Cost effectiveness is computed as the cost of intervention divided by the number of adolescents served.
Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.
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Start-up of intervention through six-month intervention period
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Cost per adolescent who makes progress on outcome measures
大体时间：Start-up of intervention through six-month intervention period
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Cost per adolescent who makes progress on outcome measures.
Cost effectiveness is computed as the cost of intervention divided by the number of positive outcomes.
The cost effectiveness ratios we compute will depend on what outcomes increase significantly relative to the comparison group.
Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.
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Start-up of intervention through six-month intervention period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Winfred (Winnie) K. Luseno, Ph.D.、Pacific Institute for Research and Evaluation
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月22日
初级完成 (估计的)
2027年5月31日
研究完成 (估计的)
2027年5月31日
研究注册日期
首次提交
2026年5月4日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 1200
- R21TW012623 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The study will share the clinical trial survey data.
IPD 共享时间框架
Data will be made available once analysis is completed or at the time of associated publication.
The duration of preservation and sharing of the data will be a minimum of 5 years after the funding period.
IPD 共享访问标准
The data shared will be made available to researchers at other institutions only per PIRE Institutional Review Board (IRB) approval and after the study is completed and primary findings are published.
The rights and privacy of participants will be protected by: (a) IRB review and approval of data sharing activities and (b) releasing only de-identified data.
De-identified data will include no information that could link it to individual participants.
It is the policy of the PIRE IRB to not share data that are personally identifiable or could lead to disclosure of the identities of individual subjects.
Moreover, we will not share data that could cause significant social or legal harm to research participants.
Data will be shared for quantitative analyses of primary outcome measures.
The dataset(s) that we share will be deposited in a repository such as openICPSR.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.