Author(s), year | Intervention level/type | Study design | Country (geographical location in country) | Study population | Intervention | Comparison | EPOC intervention classification | Participants (n) | Participant characteristics | Outcomes |
Ezeanolue, 2015 | Patient | Mixed methods including small cluster RCT | Nigeria (Enugu State) | Self-identified pregnant women ≥18 years who attended any church site. | Monthly baby showers offered health education and onsite laboratory testing including HIV testing, and mama packs for essential items during pregnancy. | Usual care. |
| 40 churches, 3002 patients. |
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Reynolds, 2010 | Patient | Cluster RCT | Kenya (Coast, Rift Valley and Western provinces) | HIV-positive pregnant women ≥18 and at least 32 weeks’ gestation. | PMTCT providers trained to prepare and counsel women on how to store and administer take-home nevirapine infant dose. | Usual care. |
| 10 clusters, 160 patients. |
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Weiss, 2014 | Patient | RCT | South Africa (Gert Sibande and Nkangala districts) | HIV-positive pregnant women, 24–30 weeks’ gestation, and ≥18 years of age, recruited and asked to invite their male partner to enrol as a couple. | 4 successive weekly sessions employed a cognitive-behavioural approach and addressed HIV, safer sex, sexual negotiation and PMTCT issues. Sessions were closed, structured, of gender-concordant groups, led by trained gender-matched facilitators and conducted in ANCs. | Time-matched health education sessions. |
| 12 clusters, 478 couples. |
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Yotebieng, 2016 | Patient | RCT | Democratic Republic of Congo (Kinshasa) | Newly diagnosed HIV-positive women, ≤32 weeks’ gestation, registering for ANC. | Participants received small, escalating cash payments, starting at US$5 and increasing by US$1 each visit, if attended scheduled clinic appointments and completed recommended actions. Incentive reset to its original value if mother failed to complete any actions required at a specific visit. | Usual care. |
| 433 women. |
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Richter, 2014 | Patient/Provider | Cluster RCT | South Africa (KwaZulu-Natal) | HIV-positive women, ≥18 years of age and <34 weeks pregnant. | 8-session intervention conducted by peer mentors (4 antenatal, 4 postnatal) to support HIV-positive women through pregnancy and early motherhood. HIV-positive women recruited, trained and certified as peer mentors prior to implementation; inperson supervision was provided weekly. | Usual care. |
| 8 clusters, 1200 patients. |
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Kieffer, 2011 | Provider | Cluster RCT | Swaziland | All pregnant women presenting for delivery at participating maternity facilities. | 1-day training course provided to nurse- midwives to increase knowledge and skills in provision of PMTCT and to enhance confidence and counselling skills. | Usual care. |
| 6 clusters, 2444 patients. |
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Dryden-Peterson, 2015 | Provider/System | Stepped-wedge cluster RCT | Botswana (Gaborone) | ART-naïve, HIV-positive women registering at antenatal clinic before 26 weeks’ gestation. | 2-hour clinical staff education sessions on protocols for CD4 testing; open-source platform permitting automated SMS to monitor/deliver CD4 results between central labs and clinics; longitudinal support for tracing women eligible for ART initiation. | Usual care. |
| 19 clusters, 336 women. |
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Mwapasa, 2017 | Provider/System | 3-arm, cluster RCT | Malawi (Salima and Mangochi districts) | HIV-positive pregnant women initiated on option B+ regimen. | MIP: integration of HIV/ANC, routine tracing. MIP+SMS: integrated HIV/ANC care, SMS sent to community health worker to trace if appointment missed. | Usual care: non-integrated care, routine tracing as for MIP. |
| 30 clusters, 1350 women. |
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Oyeledun, 2017 | Provider/System | Cluster RCT | Northern Nigeria (Benue and Kaduna states) | HIV-positive, women, gestational age ≤34 weeks, who were ART-naive and agreed to start lifelong ART. | QI teams established, visits by coaches and collaborative meetings. | Routine MOH support. |
| 32 clusters (6 later excluded), 532 women (21 withdrew, leaving 511 in total). |
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Phiri, 2017 | Provider/System | 3-arm, cluster RCT | Malawi (SE, SW and Central West Zones) | Pregnant and breastfeeding HIV-positive women and their infants. Up to three male sex partners could be enrolled per patient. | FBPS: women received SOC and met with ‘mentor mothers’, HIV-positive women who had recently completed PMTCT and were on ART. Mentor mothers provided one-on-one support at each clinic visit, led weekly clinic-based support groups and contacted women within 1 week of a missed appointment. CBPS: women received SOC and met with ‘expert mothers’, HIV-positive women who recently completed PMTCT and were on ART. Expert mothers conducted routine home visits to provide HIV education and clinic visit reminders, and led monthly community-based support group meetings. Expert mothers were responsible for contacting women in the community within 1 week of a missed clinic visit. | SOC facilities provided routine HIV care according to Malawi MOH guidelines. According to national guidelines, women who fail to attend the clinic within 60 days of a missed appointment are supposed to be traced. However, this rarely occurs in the routine programme. |
| 21 clusters, 1269 women. |
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Tomlinson, 2014 | Provider/System | Cluster RCT | South Africa (Umlazi) | Pregnant women aged ≥17 and their newborns residing in the clusters during the recruitment period. | CHWs were trained to carry out structured home visits using motivational interviewing for breastfeeding counselling. Women were scheduled to receive seven home-based visits during pregnancy and postdelivery. Low birthweight neonates received two extra visits within the first week. | In control clusters, CHWs provided information and support on accessing social welfare grants and conducted three home-based visits: during pregnancy and postdelivery. |
| 30 clusters, 3957 women. |
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Aliyu, 2016 | System | Cluster RCT | Rural north-central Nigeria (Niger State) | HIV-positive women and their infants, presenting for ANC or delivery who met one of the following criteria: unknown HIV status at presentation; history of ART prophylaxis or treatment, but not receiving ARTs at presentation; or known HIV status but had never received treatment. | Integrated package of PMTCT services that included point-of-care CD4 cell count or percentage testing, transition of decentralised PMTCT tasks to trained midwives, integrated mother and infant care services, active influential family member (male partner) participation, and community involvement (male community peer champions providing outreach, education and linkage of male partners to key referral services). | SOC included health information, opt-out HIV testing, infant feeding counselling, referral for CD4 cell counts and treatment, ART prophylaxis, and early infant diagnosis. |
| 12 clusters, 369 patients. |
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Geelhoed, 2013 | System | Cluster RCT | Mozambique (Tete Province) | Public primary health facilities providing maternal child health and PMTCT services. Mothers and their children up to 5 years of age. | Reorganised services to deliver integrated consultations and services for mothers and their children up to 5 years of age. | Usual care. |
| 6 clusters. | Not available. |
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Killam, 2010 | System | Stepped-wedge cluster RCT | Zambia (Lusaka) | ART-eligible pregnant women presenting at participating clinics. | Integration of ART care into ANC. Women already receiving ART at the general ART clinic encouraged to continue receiving their services in the general ART clinic. | Usual care. |
| 8 clusters, 31 536 patients. |
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Odeny, 2014 | System | RCT | Kenya (Nyanza region) | HIV-positive women attending antenatal or HIV care, ≥18 years of age, between 28 weeks’ gestation and delivery, enrolled in PMTCT, access to mobile phone. | Custom-built, automated software to send and receive text messages. Sent 14 text messages, up to 8 sent during pregnancy, and weekly for the first 6 weeks after delivery. | Usual care. |
| 388 patients. |
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Rotheram-Borus, 2014 | System | Cluster RCT | South Africa (Cape Town) | Pregnant women ≥18 years of age from Cape Town townships. | Antenatal and postnatal home visits by CHW in addition to standard clinic-based care. | Usual care. |
| 26 clusters (2 later removed), 1144 eligible women. |
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Rustagi, 2016 | System | Cluster RCT | Cote d’Ivoire, Kenya, Mozambique | Public and non-profit health facilities with PMTCT services. Pregnant women presenting for antenatal care. | A five-step, facility-level systems analysis and improvement intervention designed to maximise effectiveness of PMTCT service delivery by improving understanding of inefficiencies. | Usual care. |
| 36 clusters, 1876 patients. | Not available. |
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Turan, 2015 | System | Cluster RCT | Kenya (Nyanza Province) | Pregnant HIV-positive women ≥18, not enrolled in HIV care at baseline and their infants. | Integrated clinics provided PMTCT and HIV care and treatment services within existing ANC services, starting prenatally and continuing until a definitive paediatric HIV diagnosis was obtained or the child reached 18 months of age. | Non-integrated ANC clinics provided routine PMTCT services and referred HIV-positive pregnant women to a separate HIV clinic at the same facility. |
| 12 clusters, 1172 women. |
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ANC, antenatal care; ART, antiretroviral therapy; AZT, zidovudine; C, control; CHW, community health worker; EPOC, Effective Practice and Organisation of Care; FBPS, facility-based peer support; HAART, highly active antiretroviral therapy; I, intervention; MIP, methods routine paper; MOH, ministry of health; NVP, nevirapine; PMTCT, prevention of mother to child transmission; RCT, randomised controlled trial; SE, south east; SMS, short message service; SOC, standard of care; SW, south west.