HIV InfectionT2TNCT02527135
Text Messaging to Improve HIV Testing Among Young Women in Kenya
A study testing Weekly HIV sensitization text messages in people with HIV Infection, run by University of Washington at 1 site in Kenya.
Trial summary
The purpose of this study is to determine whether regularly scheduled HIV sensitization text messages (SMS) are effective in increasing HIV testing rates among young women in Kenya. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Weekly HIV sensitization text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Own a mobile phone which they don't share and which operates on a telecom provider supported by our SMS platform
- Be HIV uninfected (by self report) or not know their HIV status
- Report not having tested for HIV in the preceding 12 months
- Know how to send and receive SMS
- Must consent to the study
- Have regular access to electricity for charging a cell phone
Who cannot join
- Did not consent to the study
- Did not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Partners in Health and Research Development (PHRD)
Nairobi, Nairobi County, 00202
About this study
Official title: Evaluating Feasibility and Potential Impact of Text Messages on HIV Awareness Among Young Women in Rural Kenya: a Pilot Study
The purpose of this study is to determine whether regularly scheduled HIV sensitization text messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.
Read the detailed description
In Kenya, women have higher rates of infection (6.9%) than men (4.4%) and young women aged 15-24 years are over three times more likely to be infected than young men of the same age group. HIV testing and counseling remains critical to identifying new infections and preventing the spread of HIV but many young women do not test and still continue to engage in high risk behavior.
HIV programs have begun to leverage mobile phones and text messages to increase the reach and scale of interventions. Kenya currently has 32.2 million mobile phone subscribers, representing a 79.2% country penetration. Text messages have been used successfully in Kenya for marketing purposes and have even been demonstrated to increase antiretroviral (ART) adherence. Despite advances in mobile-based applications to improve issues in health, none of these health applications have yet been able to reach the scale of mobile phone-based financial products in Kenya.
Given the potential synergies of text message use and need for HIV testing, a randomized quasi-experimental study was conducted to test whether weekly text messages encouraging HIV testing and improving HIV awareness would increase HIV testing, enhance HIV risk perception and reduce high risk behaviour among young women 18-24 years old in a predominantly rural region in Kenya.
Women in the intervention arm received access to a suite of HIV sensitization text messages sent weekly to increase their awareness of HIV and encourage them to test with the option of texting back for more information to a maximum of three times per week. Women in the control arm did not receive these messages. All women were followed up for six months with monthly SMS surveys collecting data on their HIV testing practices, sexual behaviour and risk perception.
- Conditions
- HIV Infection
- Being tested
- Weekly HIV sensitization text messages
- Keywords
- SMS, Text messages, Young women, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly HIV sensitization text messagesBehavioural
Weekly HIV sensitization text messages with option to text back up to 3 times per week for additional messages. Message topics included pregnancy, condoms, sexually transmitted infections, contraceptives, anal sex and personal risk of HIV. All messages ended with the phrase "Get tested for HIV".
| Study group | Role | What they receive |
|---|---|---|
| Behavioural | Experimental | Intervention arm receiving weekly HIV sensitization text messages Receives: Behavioral: Weekly HIV sensitization text messages |
| Control | No intervention | No weekly messages were sent to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
First HIV test
Time to first reported HIV test will be compared between the two study arms
Measured: End of study (6 months after enrollment)
Secondary outcomes (2)
Reported sexual behaviour patterns
Sexual behaviour data (number of new sexual partners, concurrent sexual partnerships and number of sex acts where condoms are used) was collected via a text message survey monthly during study follow up and responses will be compared between the two study arms
Measured: End of study (6 months after enrollment)
Self perception of risk
Self perception of HIV risk in both arms will be compared against HIV testing habits and sexual partnerships
Measured: End of study (6 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Njambi Njuguna, University of Washington
- Investigators
- Njambi Njuguna, MBChB,MPH, Principal investigator, University of Washington; Kenyatta National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527135
- Sponsor's protocol ID
- 49533-EJ
- Other IDs
- D43TW009580, S4 0254-01
- Acronym
- T2T
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Feasibility and Potential Impact of Text Messages on HIV Awareness Among Young Women in Rural Kenya: a Pilot Study
- ClinicalTrials.gov ID
- NCT02527135
- Acronym / sponsor ID
- T2T / 49533-EJ
- Conditions
- HIV Infection
- Keywords
- SMS, Text messages, Young women, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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.
The purpose of this study is to determine whether regularly scheduled HIV sensitization text messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.
Detailed description
In Kenya, women have higher rates of infection (6.9%) than men (4.4%) and young women aged 15-24 years are over three times more likely to be infected than young men of the same age group. HIV testing and counseling remains critical to identifying new infections and preventing the spread of HIV but many young women do not test and still continue to engage in high risk behavior.
HIV programs have begun to leverage mobile phones and text messages to increase the reach and scale of interventions. Kenya currently has 32.2 million mobile phone subscribers, representing a 79.2% country penetration. Text messages have been used successfully in Kenya for marketing purposes and have even been demonstrated to increase antiretroviral (ART) adherence. Despite advances in mobile-based applications to improve issues in health, none of these health applications have yet been able to reach the scale of mobile phone-based financial products in Kenya.
Given the potential synergies of text message use and need for HIV testing, a randomized quasi-experimental study was conducted to test whether weekly text messages encouraging HIV testing and improving HIV awareness would increase HIV testing, enhance HIV risk perception and reduce high risk behaviour among young women 18-24 years old in a predominantly rural region in Kenya.
Women in the intervention arm received access to a suite of HIV sensitization text messages sent weekly to increase their awareness of HIV and encourage them to test with the option of texting back for more information to a maximum of three times per week. Women in the control arm did not receive these messages. All women were followed up for six months with monthly SMS surveys collecting data on their HIV testing practices, sexual behaviour and risk perception.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural | Experimental | Behavioral: Weekly HIV sensitization text messagesIntervention arm receiving weekly HIV sensitization text messages |
| Control | No intervention | –No weekly messages were sent to this group |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Own a mobile phone which they don't share and which operates on a telecom provider supported by our SMS platform
- Be HIV uninfected (by self report) or not know their HIV status
- Report not having tested for HIV in the preceding 12 months
- Know how to send and receive SMS
- Must consent to the study
Key exclusion criteria (2 listed)
- Did not consent to the study
- Did not meet inclusion criteria
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 |
|---|---|---|
| Weekly HIV sensitization text messagesWeekly HIV sensitization text messages with option to text back up to 3 times per week for additional messages. Message topics included pregnancy, condoms, sexually transmitted infections, contraceptives, anal sex and personal risk of HIV. All messages ended with the phrase "Get tested for HIV". | Behavioural | Behavioural |
Primary outcome
First HIV test
Time frame: End of study (6 months after enrollment)
Time to first reported HIV test will be compared between the two study arms
2 secondary outcomes
Reported sexual behaviour patterns
Time frame: End of study (6 months after enrollment)
Self perception of risk
Time frame: End of study (6 months after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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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.
Njambi Njuguna, MBChB,MPH principal investigator
University of Washington; Kenyatta National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly HIV sensitization text messages in people with HIV Infection, run by University of Washington 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 2 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: finished, as of the sponsor's last update on 18 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First HIV test (time frame: End of study (6 months after enrollment)). 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 18 Aug 2015.