Table 1 Profiles of the four PMTCT implementation research studies in Nigeria, 2012–2017
Profile indicators | Baby Shower | Optimizing PMTCT | MoMent | Lafiyan Jikin Mata |
|---|---|---|---|---|
Funder | NIH | NIH | WHO/Global Affairs Canada | WHO/Global Affairs Canada |
Implementation period | 2012–2015 | 2012–2015 | 2012–2017 | 2012–2017 |
Local PEPFAR implementing partner | Prevention, Education, Treatment, Training and Research-Global Solutions | Friends in Global Health Nigeria | Institute of Human Virology Nigeria | Center for Integrated Health Programs |
Study design | Two-arm cluster randomised controlled trial | Two-arm cluster randomised controlled trial | Two-arm prospective matched cohort study | Two-arm cluster randomised controlled trial |
Study setting | Enugu state (south east zone) | Niger state (north central zone) | Federal Capital Territory and Nasarawa states (north central zone) | Benue and Kaduna states (north central, north west zones) |
Study sites | Catholic/Anglican churches | Primary and secondary healthcare facilities | Primary healthcare facilities | Primary and secondary healthcare facilities |
Study settings | Rural and urban | Rural | Rural | Rural and urban |
Number of study sites | 40 (20 per arm) | 12 (6 per arm) | 20 (10 per arm) | 32 (16 per arm) |
Formative studies | 2 FGDs with pregnant women, male partners, women’s groups and the clergy | 3 FGDs with study participants 10 KIIs with community leaders, clinicians, and local health officials | 11 FGDs with pregnant and young women, HIV+ MMs and m2m support group members, male partners 31 KIIs with HIV+ MMs, community leaders, TBAs, HCWs and PMTCT programme implementers and policy-makers | 44 FGDs with women including HIV infected pregnant women and their male partners 42 KIIs with HCWs, community women, community and religious leaders, policy-makers |
Core interventions | Congregation-based HIV testing for pregnant women | Point-of-care CD4 testing Task shifting Integrated mother-infant service provision Male partner and community engagement | Structured, supervised peer support | Structured continuous quality improvement intervention and breakthrough collaborative series |
Control/standard of care | Routine facility-based HIV testing | Routine PMTCT services | Routine PMTCT services including informal peer support | Routine PMTCT services |
Study participants | Pregnant women of unknown HIV status Male partners | HIV+ pregnant women HIV-exposed infants | HIV+ pregnant women HIV-exposed infants | HIV + pregnant women |
Primary and key secondary outcome measures | Maternal HIV testing during pregnancy Maternal ART uptake HIV testing among male partners of pregnant women | Maternal ART uptake Maternal and infant retention at 6 and 12Â weeks postpartum Infant EID uptake by 14Â weeks of age MTCT Participant and provider satisfaction Cost-effectiveness | Infant EID presentation by 2Â months of age Maternal and infant retention over first 6 and 12Â months postpartum Maternal VL suppression at 6Â months postpartum Cost-effectiveness | Maternal retention at 6 and 12Â months postpartum Infant EID uptake by 10Â weeks of age |
Original sample size | 2700 pregnant women | 372 HIV+ pregnant women | 480 HIV+ pregnant women | 640 HIV+ pregnant women |
Revised sample size | N/A | N/A | 220 HIV+ pregnant women | 520 HIV+ pregnant women |
Final enrolment | ||||
 Pregnant women | 3054 | 369 | 497 | 511 |
 HIV-exposed infants | 69 | 380 | 408 | 403 |
 Male partners | 2498 | N/A | N/A | N/A |
Summarised results-main outcomes | Women in IG 11 times more likely to have had an HIV test Male partners in IG 12 times more likely to have had an HIV test | Women in IG 3 times more likely to initiate ART Mother-infant pairs in IG 10 times more likely to be retained in care at 12 weeks postpartum IG infants 74% less likely to acquire HIV infection at 12 weeks postpartum | Infants in IG 4 times more likely to present for timely EID by 2 months of age Mothers in IG 6 times more likely to be retained Mothers in IG 5 times more likely to be virally suppressed | No significant difference in maternal retention at 6 months postpartum Infants in IG 2 times more likely to receive timely EID testing at 4–6 weeks |
90–90–90 relevance | First 90 (testing) Second 90 (ART uptake) | Second 90 (ART uptake) Third 90 (viral suppression, presumed due to retention) | Third 90 (viral suppression via adherence) Third 90 (viral suppression, presumed due to retention) | Third 90 (viral suppression, presumed due to retention) |