1. 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

2. 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)

3. 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

4. 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

5. 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

6. STUDY PROCEDURES Recruitment Registration Arm assignment
Informed Consent
Randomization
Data entry

7. 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

8. 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.

9. 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 [ ]
0.3
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

10. 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

11. 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

12. 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 [ ]
1.79 [ ]
0.04
31-40yr
69 (40.12%)
5.12 [ ]
2.45 [ ]
0.01
>40yr
31 (36.9%)
4.47 [ ]
2.12 [ ]
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

13. 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 [ ]
1.7 [ ]
0.02 2+
52 (36.62%)
3.70 [ ]
2.3 [ ]
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

14. 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 [ ]
1.81 [ ]
0.003
Primary or lower education (vs. secondary or less)  
107 (40.4%)
2.24 [ ]
2.13 [ ]
 <0.001
Employed (vs. Unemployed)   
196 (33.85%)
2.51 [ ]
1.51 [ ]
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

15. 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

16. 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

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