mHealth InterventionNCT07587281
Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
A study testing Chatbot providing comprehensive sexuality education plus youth peer facilitators in people with mHealth Intervention, run by Pacific Institute for Research and Evaluation at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- mHealth Intervention
- What is being tested?
- Chatbot providing comprehensive sexuality education plus youth peer facilitators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteKenya
- Study dates
- 22 May 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- mHealth Intervention
- Being tested
- Chatbot providing comprehensive sexuality education plus youth peer facilitators
- Keywords
- Sex Education, Pregnancy in Adolescence, Sexually Transmitted Infections, Adolescent, Software, Prevention, Cell Phone, Sexual Health, Reproductive health, mHealth, Cost Effectiveness
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot providing comprehensive sexuality education plus youth peer facilitatorsCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| AskDoki plus Digital Champions | Experimental | 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. Receives: Combination Product: Chatbot providing comprehensive sexuality education plus youth peer facilitators |
| No access to AskDoki or Digital Champions | No intervention | Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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.
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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."
Measured: Baseline and 6 months post-intervention
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).
Measured: Baseline and 6 months post-intervention
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").
Measured: Baseline and 6 months post-intervention
Secondary outcomes (6)
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.
Measured: Baseline and 6 months post-intervention
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.
Measured: Baseline and 6 months post-intervention
Self-reported history of adolescent pregnancies
Respondents' self-reported history of pregnancy and impregnating someone. Example item: "Are you or your partner currently pregnant?""
Measured: Baseline and 6 months post-intervention
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.
Measured: Baseline and 6 months post-intervention
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.
Measured: Baseline and 6 months post-intervention
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.
Measured: Start-up of intervention through six-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start22 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mHealth InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a quasi-experimental design with a nonequivalent control cluster.
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Amref Health Africa, Michigan State University
- Responsible party
- Principal investigator, Winfred K. Luseno, Pacific Institute for Research and Evaluation
- Investigators
- Winfred (Winnie) K. Luseno, Ph.D., Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587281
- Sponsor's protocol ID
- 1200
- Other IDs
- R21TW012623
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share the clinical trial survey data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
- ClinicalTrials.gov ID
- NCT07587281
- Acronym / sponsor ID
- 1200
- Conditions
- mHealth Intervention
- Keywords
- Sex Education, Pregnancy in Adolescence, Sexually Transmitted Infections, Adolescent, Software, Prevention, Cell Phone, Sexual Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Amref Health Africa, Michigan State University
- Study start
- 22 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a quasi-experimental design with a nonequivalent control cluster.
| Arm | Type | Receives |
|---|---|---|
| AskDoki plus Digital Champions | Experimental | Combination Product: Chatbot providing comprehensive sexuality education plus youth peer facilitatorsIntervention 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. |
| No access to AskDoki or Digital Champions | No intervention | –Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot providing comprehensive sexuality education plus youth peer facilitatorsA 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. | Combination product | AskDoki plus Digital Champions |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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.
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).
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).
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."
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).
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").
6 secondary outcomes
Knowledge about sexual and reproductive health
Time frame: Baseline and 6 months post-intervention
Self-reported STI symptoms
Time frame: Baseline and 6 months post-intervention
Self-reported history of adolescent pregnancies
Time frame: Baseline and 6 months post-intervention
Intention to test and treat STIs
Time frame: Baseline and 6 months post-intervention
Intention to use SRH services
Time frame: Baseline and 6 months post-intervention
Retention of Digital Champions
Time frame: Start-up of intervention through six-month intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. The study will share the clinical trial survey data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfred (Winnie) K. Luseno, Ph.D. principal investigator
Pacific Institute for Research and Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot providing comprehensive sexuality education plus youth peer facilitators in people with mHealth Intervention, run by Pacific Institute for Research and Evaluation at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy to abstain (time frame: Baseline and 6 months post-intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.