Text Messaging after Adult Male Circumcision (SMS4MC): A Randomized Controlled Trial December 08, 2011 ICASA 2011, Addis Ababa Dr. Walter Obiero On behalf of Dr. Thomas Odeny Thomas Odeny, Robert Bailey, Elizabeth Bukusi, Jane Simoni, Kenneth Tapia, Krista Yuhas, King Holmes, Scott McClelland

Comprehensive MC package STI screening and treatment HIV testing and counseling Risk reduction counseling Male circumcision as a service for HIV prevention is provided as a package that includes: PITC, STI screening and treatment, condom promotion and provision, risk-reduction counseling & finally the surgery itself with post-surgical follow-up at 7 days Tension – clients focused on surgery and may not retain other key elements, hence need for post-operative review to reiterate key messages as well as assess wound healing status Early resumption of sex is a key concern (WHO recommendation 42 days)

1 2 3 Post-op complications HIV acquisition HIV transmission increased Early resumption of intercourse is associated with an increased risk of all surgery-related AEs: this was a major finding in this study done in Rakai, Uganda It is also potentially associated with an increased risk for HIV acquisition – this study led by Bob Bailey and Supriya Mehta pooled the data from all 3 RCTs and not find an association with increased risk of HIV sero-conversion but the authors concluded that the study was underpowered and the risk of HIV acquisition still remains. Certainly, there is biological plausibility for increased risk because a circumcision wound is essentially an iatrogenic ulcer, so that the physical barrier to infection from the skin is compromised Finally, HIV-infected men who are circumcised and then go on to resumed sex before wound healing are more likely to infect their female partners than those who delay resumption: this was from another study by the Rakai group

Intervention: SMS after MC Improve attendance of post-op visit Promote delayed resumption of sex after MC We proposed to send men text messages after circumcision to improve attendance of post-operative clinic visits, as well as reduce early resumption of sex after circumcision

Rationale Wide coverage: 77% land mass High access: 63% of Kenyan households We chose SMS in particular because there is high mobile phone coverage in Kenya. More than ¾ of the country is covered by a mobile phone network Access to mobile phones is also high. Per 2009 census, close to 2/3 of Kenyan households have access to a mobile phone SMS has also been found acceptable for receiving HIV-related information, and promoting antiretroviral adherence Rapid increase in # mobile phone connections. There are more than 22 million mobile phone subscribers in a country of 38 million Acceptable: HIV info, ARV adherence

STUDY PROCEDURES Recruitment Registration Arm assignment Informed Consent Randomization Data entry

Between September 2010 and April 2011, we screened 3500 men who had been circumcised at any of 12 study sites We excluded about 2,300 for various reasons and remained with 1,200 that we randomized to either study arm For the day 7 outcome, 12 subjects (or just 1%) were lost to follow up because their files could not be found

At day 42, 18% of patients could not be reached for the final phone interview and were classified as lost to follow-up, leaving about 82% with outcome data for resumption of sex before day 42 . Power calculations with 11% LTF in mind. Study slightly under-powered due to 18% LTF.

Primary outcomes SMS group Control group RR [95% CI] p-value   SMS group Control group RR [95% CI] p-value Resumption of sex 140/491 (28.3%) 125/493 (25.2%) 1.1 [0.91-1.38] 0.3 For resumption of sex before 42 days, 27% of men overall reported early resumption The proportion reporting resumption of sex before 42 days did not differ between the SMS and control groups

Time-to-resumption of sex Log rank test; p=0.31 When we compared the time to resumption of sex between the two study arms, the difference was not statistically significant Of note on this Kaplan-Meier curve is the fact that the biggest drops occur in weeks 4, 5 and 6

Proportion resuming sex by week Log rank test; p=0.31 And this graph shows it in a different way: that 92% (n=263) of men who resumed sex did so in weeks 4, 5 and 6. This finding may be useful for timing of interventions for encouraging delayed resumption

Multiple Logistic Regression Resumed Sex UnadjustedOR [95% CI] Adjusted OR [95% CI] p-value Age group   18-20yr 20 (11.56%) 1 (ref) -- 21-30yr 145 (25.94%) 2.68 [1.62-4.43] 1.79 [1.04-3.07] 0.04 31-40yr 69 (40.12%) 5.12 [2.94-8.94] 2.45 [1.29-4.64] 0.01 >40yr 31 (36.9%) 4.47 [2.35-8.51] 2.12 [1.03-4.37] Age was an important predictor of early resumption of sex, with a progressive stepwise increase in the odds ratio with age It remained significant after adjustment

Multiple Logistic Regression Resumed Sex Unadjusted OR [95% CI] Adjusted OR [95% CI] p-value Sex partners in past month    34 (13.49%) 1 (ref) -- 1 179 (30.13%) 2.77 [1.85-4.13] 1.7 [1.10-2.63] 0.02 2+ 52 (36.62%) 3.70 [2.25-6.09] 2.3 [1.35-3.90] 0.002 Number of sex partners reported in the month prior to circumcision was also a significant predictor of early resumption, also with a stepwise increase in the odds ratio. It also remained significant after adjustment

Multiple Logistic Regression Resumed Sex Unadjusted OR [95% CI] Adjusted OR [95% CI] p-value Married or living w/partner (versus no partner)     206 (35.70%) 3.31 [2.4-4.58] 1.81 [1.23-2.66] 0.003 Primary or lower education (vs. secondary or less)   107 (40.4%) 2.24 [1.81-3.31] 2.13 [1.54-2.94]  <0.001 Employed (vs. Unemployed)    196 (33.85%) 2.51 [1.84-3.43] 1.51 [1.07-2.14] 0.02 Being married or living with a partner was associated with higher odds of resuming sex early than having no partner Secondary education or higher was associated with lower odds of resuming sex early than primary education or less Being employed was associated with higher odds of resuming sex early than being unemployed

Main findings SMS did not have a significant effect on resumption of sex before 42 days post-circumcision Risk factors for early resumption of sex identified Married or living with a partner Having one or more sex partners in month prior to MC Blinding not possible Social desirability bias Limitations 18% LTF Low education level Employment

Early Resumption of Sex 27% reported resumption before 42 days Overall proportion similar to Orange Farm RCT Other factors associated with resumption age, marital status, # sexual partners, education, employment More insight needed Qualitative studies for more targeted interventions

Acknowledgements R. Scott McClelland Elizabeth Bukusi Jane Simoni Robert Bailey King K. Holmes NRHS Impact RDO FACES IARTP UW CFAR Biometrics Core