CClinicalTrials.gg
Active, not recruitingNCT07587281Updated Sep 17, 2026

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

An interventional study of Chatbot providing comprehensive sexuality education plus youth peer facilitators in mHealth Intervention, sponsored by Pacific Institute for Research and Evaluation. Active, not recruiting at 1 site in Kenya. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Pacific Institute for Research and Evaluation · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
610
Allocation
Non-randomized
Ages
15 Years to 19 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • mHealth Intervention

Keywords

  • Sex Education
  • Pregnancy in Adolescence
  • Sexually Transmitted Infections
  • Adolescent
  • Software
  • Prevention
  • Cell Phone
  • Sexual Health
  • Reproductive health
  • mHealth
  • Cost Effectiveness
03

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Adolescent participants

Inclusion criteria

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
610 participants (estimated)

Study arms

  • Experimental
    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.

    Combination Product: Chatbot providing comprehensive sexuality education plus youth peer facilitators

  • No intervention
    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.

Interventions

  • Combination productChatbot 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.

05

What researchers measure

Primary outcomes

  1. Self-efficacy to abstain

    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).

    Time frame: Baseline and 6 months post-intervention

  2. Sexual self-efficacy

    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).

    Time frame: Baseline and 6 months post-intervention

  3. Perceived advantages of delaying sex

    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).

    Time frame: Baseline and 6 months post-intervention

  4. Perceived disadvantages of delaying sex

    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).

    Time frame: Baseline and 6 months post-intervention

  5. Attitudes towards condoms

    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).

    Time frame: Baseline and 6 months post-intervention

  6. Perceived norms of delaying sex

    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).

    Time frame: Baseline and 6 months post-intervention

  7. Subjective norms about condoms

    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).

    Time frame: Baseline and 6 months post-intervention

  8. Intention to abstain from sex

    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.

    Time frame: Baseline and 6 months post-intervention

  9. Intentions to use condoms

    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).

    Time frame: Baseline and 6 months post-intervention

  10. Sexual Behavior

    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).

    Time frame: Baseline and 6 months post-intervention

  11. Frequency of sexual activity

    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."

    Time frame: Baseline and 6 months post-intervention

  12. Condom use at last sex

    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).

    Time frame: Baseline and 6 months post-intervention

  13. Condom use consistency

    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").

    Time frame: Baseline and 6 months post-intervention

Secondary outcomes

  1. Knowledge about sexual and reproductive health

    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.

    Time frame: Baseline and 6 months post-intervention

  2. Self-reported STI symptoms

    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.

    Time frame: Baseline and 6 months post-intervention

  3. Self-reported history of adolescent pregnancies

    Respondents' self-reported history of pregnancy and impregnating someone. Example item: "Are you or your partner currently pregnant?""

    Time frame: Baseline and 6 months post-intervention

  4. Intention to test and treat STIs

    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.

    Time frame: Baseline and 6 months post-intervention

  5. Intention to use SRH services

    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.

    Time frame: Baseline and 6 months post-intervention

  6. Retention of Digital Champions

    Percent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.

    Time frame: Start-up of intervention through six-month intervention period

Other outcomes

  1. Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses

    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.

    Time frame: Immediately post-intervention

  2. Cost per adolescent served.

    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.

    Time frame: Start-up of intervention through six-month intervention period

  3. Cost per adolescent who makes progress on outcome measures

    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.

    Time frame: Start-up of intervention through six-month intervention period

06

Study locations

1 site
  • Amref Health Africa in Kenya
    Nairobi, Kenya
07

References and documents

Individual participant data

Plan to share: Yes — The study will share the clinical trial survey data.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07587281
Lead sponsor
Pacific Institute for Research and Evaluation
Collaborators
Fogarty International Center of the National Institute of Health, Amref Health Africa, Michigan State University
Responsible party
Winfred K. Luseno (Senior Research Scientist, Pacific Institute for Research and Evaluation) — Principal investigator
First posted
May 14, 2026
Start date
May 22, 2026
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Winfred (Winnie) K. Luseno, Ph.D.
principal investigator · Pacific Institute for Research and Evaluation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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