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.
調査の概要
状態
状態
積極的、募集していない
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (推定)
入学
610
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Winfred (Winnie) K. Luseno, Ph.D.
- 電話番号：919-265-2618
- メール：wluseno@pire.org
研究場所
-
-
-
Nairobi、ケニア
- Amref Health Africa in Kenya
-
-
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
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
はい
説明
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.
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-efficacy to abstain
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Sexual self-efficacy
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Perceived advantages of delaying sex
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Perceived disadvantages of delaying sex
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Attitudes towards condoms
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Perceived norms of delaying sex
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Subjective norms about condoms
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Intention to abstain from sex
時間枠：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. |
Baseline and 6 months post-intervention
|
|
Intentions to use condoms
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Sexual Behavior
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Frequency of sexual activity
時間枠：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."
|
Baseline and 6 months post-intervention
|
|
Condom use at last sex
時間枠：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).
|
Baseline and 6 months post-intervention
|
|
Condom use consistency
時間枠：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").
|
Baseline and 6 months post-intervention
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knowledge about sexual and reproductive health
時間枠：Baseline and 6 months post-intervention
|
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.
|
Baseline and 6 months post-intervention
|
|
Self-reported STI symptoms
時間枠：Baseline and 6 months post-intervention
|
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.
|
Baseline and 6 months post-intervention
|
|
Self-reported history of adolescent pregnancies
時間枠：Baseline and 6 months post-intervention
|
Respondents' self-reported history of pregnancy and impregnating someone.
Example item: "Are you or your partner currently pregnant?""
|
Baseline and 6 months post-intervention
|
|
Intention to test and treat STIs
時間枠：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.
|
Baseline and 6 months post-intervention
|
|
Intention to use SRH services
時間枠：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.
|
Baseline and 6 months post-intervention
|
|
Retention of Digital Champions
時間枠：Start-up of intervention through six-month intervention period
|
Percent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.
|
Start-up of intervention through six-month intervention period
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
時間枠：Immediately post-intervention
|
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.
|
Immediately post-intervention
|
|
Cost per adolescent served.
時間枠：Start-up of intervention through six-month intervention period
|
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.
|
Start-up of intervention through six-month intervention period
|
|
Cost per adolescent who makes progress on outcome measures
時間枠：Start-up of intervention through six-month intervention period
|
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.
|
Start-up of intervention through six-month intervention period
|
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。
協力者
協力者
捜査官
捜査官
- 主任研究者：Winfred (Winnie) K. Luseno, Ph.D.、Pacific Institute for Research and Evaluation
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)
研究開始
2026年5月22日
一次修了 (推定)
一次修了
2027年5月31日
研究の完了 (推定)
研究の完了
2027年5月31日
試験登録日
最初に提出
最初に提出
2026年5月4日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
最初の投稿
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月17日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
最終確認日
2026年9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
その他の研究ID番号
- 1200
- R21TW012623 (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?
はい
IPD プランの説明
The study will share the clinical trial survey data.
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。