Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
2026년 5월 12일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
610
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Winfred (Winnie) K. Luseno, Ph.D.
- 전화번호: 919-265-2618
- 이메일: wluseno@pire.org
연구 장소
-
-
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Nairobi, 케냐
- Amref Health Africa in Kenya
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연락하다:
- Anne M. Gitimu, MPH, MPPM
- 전화번호: +254721947017
- 이메일: anne.gitimu@amref.org
-
수석 연구원:
- Anne M. Gitimu, MPPM, MPH
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-efficacy to abstain
기간: 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).
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Baseline and 6 months post-intervention
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Sexual self-efficacy
기간: 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
기간: 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
기간: 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
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Attitudes towards condoms
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
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Baseline and 6 months post-intervention
|
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Sexual Behavior
기간: 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
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|
Frequency of sexual activity
기간: 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
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|
Condom use at last sex
기간: 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).
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Baseline and 6 months post-intervention
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|
Condom use consistency
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knowledge about sexual and reproductive health
기간: 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
|
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Self-reported STI symptoms
기간: 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.
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Baseline and 6 months post-intervention
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Self-reported history of adolescent pregnancies
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
기간: 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.
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Immediately post-intervention
|
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Cost per adolescent served.
기간: 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.
|
Start-up of intervention through six-month intervention period
|
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Cost per adolescent who makes progress on outcome measures
기간: 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.
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Start-up of intervention through six-month intervention period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 22일
기본 완료 (추정된)
2027년 4월 30일
연구 완료 (추정된)
2027년 4월 30일
연구 등록 날짜
최초 제출
2026년 5월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1200
- R21TW012623 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The study will share the clinical trial survey data.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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