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

May 12, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Winfred (Winnie) K. Luseno, Ph.D.
  • Phone Number: 919-265-2618
  • Email: wluseno@pire.org

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Amref Health Africa in Kenya
        • Contact:
        • Principal Investigator:
          • Anne M. Gitimu, MPPM, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy to abstain
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge about sexual and reproductive health
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
Time Frame: 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.
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific Institute for Research and Evaluation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fogarty International Center of the National Institute of Health
Michigan State University
Amref Health Africa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1200
  • R21TW012623 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will share the clinical trial survey data.

IPD Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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