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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07587281
Enrollment
610
Registered
2026-05-14
Start date
2026-05-22
Completion date
2027-05-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mHealth Intervention

Keywords

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

Brief 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.

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.

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.

Sponsors

Pacific Institute for Research and Evaluation
Lead SponsorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
Amref Health Africa
CollaboratorOTHER
Michigan State University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The study uses a quasi-experimental design with a nonequivalent control cluster.

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy to abstainBaseline and 6 months post-interventionChange 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-efficacyBaseline and 6 months post-interventionChange 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 sexBaseline and 6 months post-interventionChange 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 sexBaseline and 6 months post-interventionChange 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 condomsBaseline and 6 months post-interventionChange 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 sexBaseline and 6 months post-interventionChange 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 condomsBaseline and 6 months post-interventionChange 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 sexBaseline and 6 months post-interventionChange 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 condomsBaseline and 6 months post-interventionChange 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 BehaviorBaseline and 6 months post-interventionChange 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 activityBaseline and 6 months post-interventionChange 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 sexBaseline and 6 months post-interventionCondom 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 consistencyBaseline and 6 months post-interventionCondom 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").

Secondary

MeasureTime frameDescription
Knowledge about sexual and reproductive healthBaseline and 6 months post-interventionMeasures 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.
Self-reported STI symptomsBaseline and 6 months post-interventionRespondents' 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.
Self-reported history of adolescent pregnanciesBaseline and 6 months post-interventionRespondents' self-reported history of pregnancy and impregnating someone. Example item: "Are you or your partner currently pregnant?""
Intention to test and treat STIsBaseline and 6 months post-interventionTwo 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.
Intention to use SRH servicesBaseline and 6 months post-interventionIncrease 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.
Retention of Digital ChampionsStart-up of intervention through six-month intervention periodPercent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.

Countries

Kenya

Contacts

PRINCIPAL_INVESTIGATORWinfred (Winnie) K. Luseno, Ph.D.

Pacific Institute for Research and Evaluation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026