Strategies for Recruiting Male Partners in Malawi’s Option B+ Program: A Randomized Controlled Trial Nora E. Rosenberg, PhD T. Mtande, F. Saidi, C. Stanley, E. Jere, L. Mwangomba, K. Kumwenda, I. Mofolo, M. Mwale, A. Chauma, W.C. Miller, I. Hoffman, M. Hosseinipour July 20, 2015

Option B+ in Malawi Free lifelong ART to all HIV-infected pregnant and lactating women on the day of HIV diagnosis. Substantial increases in ART uptake, decreases in MTCT. Early loss to follow-up is common (Tenthani, 2014). Lack of disclosure to a male partner may contribute to early loss.

Disclosure through Couple HTC Couple HIV Testing and Counseling (HTC) can support: HIV status awareness and HIV status disclosure Linkage to care Maternal and infant outcomes (Kalembo, 2013, Aluisio, 2011) Consistent condom use (Rosenberg, 2014) Few women present with a partner for couple HTC. 11%, Bwaila District Hospital (Mphonda, 2014) Could active male partner recruitment enhance uptake of couple HTC?

Aims Assess acceptability of a male partner recruitment intervention within an Option B+ setting. Compare an invitation only strategy to an invitation plus tracing strategy for the primary outcome of couple HTC. Compare these two strategies for short-term secondary outcomes: male HIV status, female one-month loss, condom uptake. Observe social harms.

Randomized Controlled Trial HIV-infected pregnant women eligible for Option B+ (N=200) Invitation Only (N=100) Invitation + Tracing (N=100) >18 or emancipated minor, planning to remain in Lilongwe for one month, partner in Lilongwe, did not receive couple HTC already. March-December 2014 at Bwaila District Hospital.

Invitation + Tracing Invitation Only Day 0: Female initial visit Invitation Day 0: Female initial visit Invitation Contract Day 1-7: Couple HTC Day 7: Couple fails to present Day 30: Female Follow-up Day 8-21: Tracing Phone Community Day 1-7: Couple HTC Day 7: Couple fails to present Visit Schedule

Screened N=336 Ineligible N=116 (35%) <16 years, N=2 No partner in Lilongwe, N=98 Received couple HTC already, N=6* Woman leaving Lilongwe, N=9 Eligible N=220 (65%) Enrolled N=200 (91%) Refused N=20 (9%) Invitation Only N=100 (50%) Invitation + Tracing N=100 (50%) Eligibility and Acceptability Mean age was 27. Nearly all planned to invite partners they were married to, living with, and the father of the current pregnancy.

Couple HTC Uptake Invitation plus tracing was more effective (p=0.001).

Tracing initiation Invitation only Invitation plus tracing

Invitation onlyInvitation + Tracing P-value Male HIV status Known HIV+21%27% New HIV+50%45% HIV-29%28%0.8 Female one-month loss17%9%0.09Condom initiation48%61%0.08

3/180 women (2%) reported social harms: Blame (N=1) Separation (N=2) No intimate partner violence

Uncertain mechanisms Small sample size Single site Short-term follow-up Primary partners only

Most HIV-infected pregnant women were willing to participate. Invitation plus tracing led to: Higher uptake of couple HTC Identification of many HIV-infected men, HIV-discordant couples Better female one-month retention Higher uptake of condoms Invitation plus tracing within an Option B+ program can be an acceptable, effective, safe way of increasing couple HTC and ultimately supporting targets and the PMTCT cascade.

Co-Investigators Mina Hosseinipour, Co-PI Friday Saidi Irving Hoffman William C. Miller Innocent Mofolo Mwawi Mwale Annie Chauma Study Team Tiwonge Mtande Lusubiro Mwangomba Edward Jere Kondwane Kumwenda Christopher Stanley Rebecca Gross Blake Hauser Olivia Yambeni Wingston Ng’ambi Sophie Mtombosola Sarah Chirwa Funding CFAR Developmental Award (P30 AI50410) Fogarty Global Health Fellows Program (R25 TW009340) National Institute of Mental Health (K99 MH A1) Study participants “Please assist those who are less privileged than I am because many are living in fear of coming out in the open to talk to doctors like you. So invite them and talk to them.” -Male participant, invitation plus tracing arm, HIV-positive