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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| Kenya Medical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text Message | Experimental | Context-sensitive text messages are sent to men after undergoing circumcision |
|
| Usual Care | No Intervention | Usual care after adult male circumcision (no text messages) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Other | Context-sensitive text messages are sent to men after undergoing circumcision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.' | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resumption of sex by study arm | 42 days | |
| Correlates of failure to attend the scheduled 7-day post-operative visit | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Odeny, MBChB, MPH | University of Washington | Principal Investigator |
| R S McClelland, MD, MPH | University of Washington | Study Chair |
| Elizabeth A Bukusi, MBChB, MMed, MPH, PhD | Kenya Medical Research Institute | Study Chair |
| Jane Simoni, PhD | University of Washington | Study Chair |
| King K Holmes, MD, PhD | University of Washington | Study Chair |
| Robert C Bailey, PhD, MPH | University of Illinois at Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyanza Reproductive Health Society | Kisumu | Nyanza | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22957034 | Result | 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. | |
| 23846561 | Result |
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| Odeny 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D010349 | Patient Compliance |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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