Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
14 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
610
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Nairobi, Kenia
- Amref Health Africa in Kenya
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Combinatie product: Chatbot providing comprehensive sexuality education plus youth peer facilitators
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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Self-efficacy to abstain
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Knowledge about sexual and reproductive health
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and 6 months post-intervention
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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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 mei 2026
Primaire voltooiing (Geschat)
31 mei 2027
Studie voltooiing (Geschat)
31 mei 2027
Studieregistratiedata
Eerst ingediend
4 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 mei 2026
Eerst geplaatst (Werkelijk)
14 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
14 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1200
- R21TW012623 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
The study will share the clinical trial survey data.
IPD-tijdsbestek voor delen
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-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .