HIV InfectionsNCT01186575
Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision
A study testing Text Message in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of Washington at 1 site in Kenya.
Trial summary
Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male
- What is being tested?
- Text Message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2010to Jun 2011
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 18 years or older
- Have undergone circumcision on the day they are screened for the study
- Currently own a mobile phone with text-messaging capability, and
- Have the mobile phone in their possession at the time of enrollment
- Able and willing to respond to a questionnaire administered via a phone call
Who cannot join
- Prior participation in a study on male circumcision
- Currently participating in other ongoing research studies
- Any medical condition or situation exists such that study participation would not be in the man's best interest, as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Text Messaging to Improve Adherence to Post-Operative Clinic Appointments and Reduce Early Resumption of Sexual Intercourse After Adult Male Circumcision: A Randomized Controlled Trial
Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.
Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.
To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Patient Compliance, Cellular Phone
- Being tested
- Text Message
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Coitus, Patient Compliance, Cellular Phone
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Patient Compliance, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageOther
Also called SMS, short message service, text messaging
Context-sensitive text messages are sent to men after undergoing circumcision
| Study group | Role | What they receive |
|---|---|---|
| Text Message | Experimental | Context-sensitive text messages are sent to men after undergoing circumcision Receives: Other: Text Message |
| Usual Care | No intervention | Usual care after adult male circumcision (no text messages) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men failing to return for a post-operative clinic visit at 7 days.
This proportion will be determined by examining each participant's clinic records after their 7th post-operative day. Adherence to this clinic visit will be analyzed as a dichotomous variable.
Measured: 7 days
Proportion of men who report resumption of sexual activity before 42 days post-circumcision.
This proportion will be determined by self-report using a brief questionnaire delivered via phone call. The analysis will be as a dichotomous variable, with participants considered as having either 'resumed' or 'not resumed.'
Measured: 42 days
Secondary outcomes (2)
Time to resumption of sex by study arm
Measured: 42 days
Correlates of failure to attend the scheduled 7-day post-operative visit
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Thomas Odeny, University of Washington
- Investigators
- Thomas A Odeny, MBChB, MPH, Principal investigator, University of WashingtonR S McClelland, MD, MPH, Study chair, University of WashingtonElizabeth A Bukusi, MBChB, MMed, MPH, PhD, Study chair, Kenya Medical Research InstituteJane Simoni, PhD, Study chair, University of WashingtonKing K Holmes, MD, PhD, Study chair, University of WashingtonRobert C Bailey, PhD, MPH, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186575
- Sponsor's protocol ID
- 38465-E/G
- Status last verified
- Jan 2015
- First submitted
- 19 Aug 2010
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial. PLoS One. 2012;7(9):e43832. doi: 10.1371/journal.pone.0043832. Epub 2012 Sep 5.
PubMed 22957034Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Effect of text messaging to deter early resumption of sexual activity after male circumcision for HIV prevention: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e50-7. doi: 10.1097/QAI.0b013e3182a0a050.
PubMed 23846561
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Improve Adherence to Post-Operative Clinic Appointments and Reduce Early Resumption of Sexual Intercourse After Adult Male Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01186575
- Acronym / sponsor ID
- 38465-E/G
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Patient Compliance, Cellular Phone
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, Circumcision, Male, Coitus, Patient Compliance, Cellular Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Kenya Medical Research Institute
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Aug 2010 (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.
Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.
Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.
To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message | Experimental | Other: Text MessageContext-sensitive text messages are sent to men after undergoing circumcision |
| Usual Care | No intervention | –Usual care after adult male circumcision (no text messages) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- 18 years or older
- Have undergone circumcision on the day they are screened for the study
- Currently own a mobile phone with text-messaging capability, and
- Have the mobile phone in their possession at the time of enrollment
Key exclusion criteria (3 listed)
- Prior participation in a study on male circumcision
- Currently participating in other ongoing research studies
- Any medical condition or situation exists such that study participation would not be in the man's best interest, as determined by the investigator
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 |
|---|---|---|
| Text MessageAlso: SMS, short message service, text messagingContext-sensitive text messages are sent to men after undergoing circumcision | Other | Text Message |
Primary outcome
Proportion of men failing to return for a post-operative clinic visit at 7 days.
Time frame: 7 days
This proportion will be determined by examining each participant's clinic records after their 7th post-operative day. Adherence to this clinic visit will be analyzed as a dichotomous variable.
Proportion of men who report resumption of sexual activity before 42 days post-circumcision.
Time frame: 42 days
This proportion will be determined by self-report using a brief questionnaire delivered via phone call. The analysis will be as a dichotomous variable, with participants considered as having either 'resumed' or 'not resumed.'
2 secondary outcomes
Time to resumption of sex by study arm
Time frame: 42 days
Correlates of failure to attend the scheduled 7-day post-operative visit
Time frame: 42 days
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 16 Jan 2015.
- Results publication: PubMed 22957034Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial. PLoS One. 2012;7(9):e43832. doi: 10.1371/journal.pone.0043832. Epub 2012 Sep 5.
- Results publication: PubMed 23846561Odeny TA, Bailey RC, Bukusi EA, Simoni JM, Tapia KA, Yuhas K, Holmes KK, McClelland RS. Effect of text messaging to deter early resumption of sexual activity after male circumcision for HIV prevention: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e50-7. doi: 10.1097/QAI.0b013e3182a0a050.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Thomas A Odeny, MBChB, MPH principal investigator
University of Washington
R S McClelland, MD, MPH study chair
University of Washington
Elizabeth A Bukusi, MBChB, MMed, MPH, PhD study chair
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message in people with HIV Infections and Acquired Immunodeficiency Syndrome, 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 3 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 16 Jan 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?
Proportion of men failing to return for a post-operative clinic visit at 7 days. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186575, which also lists 2 linked publications.
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 16 Jan 2015.