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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02527135
Other study ID # 49533-EJ
Secondary ID D43TW009580S4 02
Status Completed
Phase N/A
First received August 14, 2015
Last updated August 14, 2015
Start date September 2013
Est. completion date August 2014

Study information

Verified date August 2015
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority Kenya: Ethical Review Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Did not consent to the study

- Did not meet inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Weekly HIV sensitization text messages
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".

Locations

Country Name City State
Kenya Partners in Health and Research Development (PHRD) Nairobi

Sponsors (4)

Lead Sponsor Collaborator
University of Washington Grand Challenges Canada, John E. Fogarty International Center (FIC), National Institutes of Health (NIH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary First HIV test Time to first reported HIV test will be compared between the two study arms End of study (6 months after enrollment) No
Secondary 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 End of study (6 months after enrollment) No
Secondary Self perception of risk Self perception of HIV risk in both arms will be compared against HIV testing habits and sexual partnerships End of study (6 months after enrollment) No
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