1. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Home Visits during Pregnancy Enhance Male Partner HIV Testing: A Randomized Clinical Trial Alfred Osoti MBChB MMed MPH Department of Epidemiology University of Washington 7 TH IAS Conference on HIV Pathogenesis, Treatment and Prevention

2. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Benefits of male partner involvement HIV infected pregnant woman Improve uptake of PMTCT Enhance infant HIV free survival HIV uninfected pregnant woman Reduce high maternal HIV incidence in discordant relationships Aluisio et al. JAIDS 2011 Kinuthia et al. CHR 2010

3. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Male partner involvement is low CountryTested (%) Author (Year) Uganda1.8Kizito (2008) Zimbabwe7.0Chandisarewa (2007) Zambia9.2Semrau (2005) Tanzania12.5Msuya (2008) Kenya15.0Farquhar (2005) Cote d’Ivoire19.6Brou (2007) Multi- country 21.5Orne-Gliemann (2013)* South Africa32.0Mohlala (2011) www.pepfar.gov/press/81257.htm Male HIV testing considered “marker” of male partner involvement All studies were facility based * Cameroon, India, Georgia, Dominican Republic

4. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Enhancing male partner involvement How else can we reach these men if they will not come to clinic?

5. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Home-based HIV Counseling and Testing (HBCT) Door-to-door HBCT –Acceptability >70% –Testers ~25% men ~13% couples ≈4 % pregnancy For PMTCT, it may be more efficient to focus on testing men when their partners are pregnant Alsop Z. Lancet 2010. Naik BMC Public Health 2012.

6. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Men as Partners in PMTCT (MAP) study Primary objective Compare effectiveness of home visit vs. invitation for clinic visit in increasing male partner HIV counseling and testing among women seeking prenatal care Secondary objectives Evaluate relationship stability and intimate partner violence following male partner HIV testing

7. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Study population and setting Study population Pregnant women unaccompanied by partners On 1 st antenatal care (ANC) visit Legal age No couple HCT in this pregnancy Reside in area with partner for ≥ 6 weeks Ahero Sub-district Hospital, Nyanza, Kenya Antenatal HIV-1 prevalence ~ 20% Nyanza 13.9% National 6.3% HIV prevalence

8. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Study population and setting Study population Pregnant women unaccompanied by partners On 1 st antenatal care (ANC) visit Legal age No couple HCT in this pregnancy Reside in area with partner for ≥ 6 weeks Ahero Sub-district Hospital, Nyanza, Kenya Antenatal HIV-1 prevalence ~ 20% Nyanza 13.9% National 6.3% HIV prevalence

9. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Immediate Home Visit (ACASI & Couple HCT) Invitation for Clinic Visit (ACASI & Couple HCT) Intimate partner violence Relationship stability Randomization Antenatal HCT Male partners tested for HIV, through Couple HCT Design: a randomized controlled trial Screening, Enrollment, Interview [Audio Computer Assisted Self Interview (ACASI)]

10. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 495 screened during 1 st ANC visit 150 home visit 150 clinic visit 312 (63%) eligible 300 (96%) randomized Results: Enrollment and follow-up of women 183 (37%) ineligible 12 (4%) declined 149 (99%) followed-up 150 (100%) followed-up 1 loss to follow-up

11. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Results: baseline characteristics of women Characteristic Home visit (N=150) Clinic visit (N=150) Number (%) or Median (IQR) Age (years) 22 (20,25) 22 (20,26) Highest education level Primary or lower 103 (69%) 99 (66%) Marital status Monogamous 131 (87%) 131 (87%) Economic status Daily household income <2 $ 111 (74%) 113 (75%) Daily cell phone use107(71%)116(77%) Physical threat from male partner (past 6 months) 34 (23%) 36 (24%) HIV prevalence 21 (14%) 27 (18%) $=United States dollars

12. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 133 (89%) male partners accessed 55 (37%) male partners accessed Results: male partner access and HIV testing 128 (85%) male partners HIV tested 54 (36%) male partners HIV tested HOME VISIT (150 women enrolled) CLINIC VISIT (150 women enrolled)

13. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Results: Main outcomes Outcome Home visit (%) Clinic visit (%) RR95% CIP value Male partner HIV testing and mutual disclosure85362.371.90-2.96<0.001* Reported improved quality of relationship 6728 2.361.79-3.13<0.001* Physically threatened over the past six months16190.850.51-1.430.544 *Statistically significant RR=Relative Risk CI= Confidence interval

14. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Results: overall male partner HIV status Male partner HIV StatusHome visitClinic visitRR95%CIP value No(%)No(%) HIV positive18(12.0)12(8.0)1.50.74-3.000.248 HIV negative110(73.3)42(28.0)2.621.99-3.45<0.001* HIV discordant22(14.7)7(4.7)3.141.38-7.130.003* HIV concordant positive7(4.7)8(5.3)0.880.33-2.350.791 *Statistically significant RR=Relative Risk CI= Confidence interval

15. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Results: relationship status at follow-up P<0.001 P=1.000 P= 0.767

16. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Strengths and limitations Strengths Randomized design Generalizable to high HIV prevalence and resource- limited settings with similar partnerships Easily implementable, conducted after routine prenatal HCT Limitations Excluded single and those in unstable relationships Short follow-up period, unable to assess long-term outcomes such as HIV free survival, linkage to care, cost-effectiveness

17. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Conclusions Home visits for male partner testing and mutual disclosure –highly acceptable –enhanced access to male partners and couple HCT (85%) –did not adversely affect short-term relationship status –found high prevalence of HIV among male partners HIV serodiscordant couples

18. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Acknowledgements University of Washington Carey Farquhar Grace John-Stewart Barbra Richardson Daisy Krakowiak International AIDS Research and Training Program Study Participants and Staff University of Nairobi James Kiarie John Kinuthia Funding: NIH, Fogarty International Centre

19. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 THANK YOU!

20. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Enrollment status Ineligibility (n=183): – 14 accompanied by male partner – 32 male partners or themselves away for > 6 weeks – 53 HIV positive and knew before pregnancy – 38 single with no stable male partner – 25 single, primary to high school students – 9 separated from male partners – 2 widows – 2 non-pregnant (negative pregnancy test) – 8 visitors, not residents of the area Reasons for declining (n=12): – 5 consult partner – 4 time constraints – 3 another study