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Peer-reviewedCC BYBMJ Open

Impact of breastfeeding beyond 12 months on HIV transmission, mortality and morbidity among HIV-exposed uninfected infants in sub-Saharan Africa: a protocol for a systematic review and meta-analysis

  • Juliet Asio Nkugwa1,2
  • Nicolette Nabukeera-Barungi3
  • Joseph Rujumba3
  • Erick Jacob Okek4,5
  • Phoebe Namukanja Mayambala Monalisa6
  • Eleanor Namusoke Magongo7,8
  • Seth Inzaule9
  • Bernard Kikaire3,10
10 affiliations
  1. 1Paediatrics, Makerere University College of Health Sciences, Kampala, Uganda
  2. 2General Virology, Uganda Virus Research Institute, Entebbe, Uganda
  3. 3Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda
  4. 4Zoonotics, Uganda Virus Research Institute, Kampala, Entebbe, Uganda
  5. 5Immunology & Molecular Biology, Makerere University CHS, Kampala, Uganda
  6. 6U.S. Centers for Disease Control and Prevention, Division of Global HIV & TB, Kampala, Uganda
  7. 7The AIDS Control Programme, Ministry of Health, Kampala, Uganda
  8. 8Washington University in St Louis, St Louis, Washington, USA
  9. 9Amsterdam Institute of Global Health and Development, Amsterdam, The Netherlands
  10. 10Uganda Virus Research Institute, Entebbe, Uganda
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Abstract

Introduction Globally, over 1.1 million HIV-exposed uninfected (HEU) infants are born annually, predominantly in sub-Saharan Africa (SSA). Despite effective prevention of mother-to-child transmission programmes, HEU infants face disproportionately higher risks of malnutrition, morbidity and mortality compared with HIV-unexposed peers. Uncertainty remains about the optimal duration of breastfeeding in this population. Most SSA national guidelines recommend cessation at 12 months, yet emerging evidence suggests that early cessation may increase malnutrition and mortality risk, particularly in resource-limited settings. No recent systematic review has comprehensively synthesised evidence on the effects of extended breastfeeding beyond 12 months on key health outcomes among HEU infants.Methods and analysis This systematic review will include randomised controlled trials (RCTs), quasi-RCTs and prospective and retrospective cohort studies comparing health outcomes in HEU infants breastfed beyond 12 months versus those breastfed for 12 months or less. Electronic databases to be searched include MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Health Sciences Literature, African Index Medicus and Web of Science, from 1 January 2013 to 31 December 2025. Two independent reviewers will screen studies, extract data and assess risk of bias using the Cochrane Risk of Bias tool and the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tools. The primary outcome is the incidence of postnatal HIV transmission. Secondary outcomes include all-cause infant mortality, nutritional status (stunting, wasting, underweight) and morbidity (pneumonia and diarrhoea). Both pairwise and network meta-analyses will be conducted using random-effects models. Evidence certainty will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Ethics and dissemination This study is a systematic review and meta-analysis of previously published studies and does not involve collection of new data from human participants. As such, ethical approval from an Institutional Review Board or Ethics Committee was not required. Findings will be disseminated through a peer-reviewed publication, conference presentations, policy briefs and stakeholder engagement with national and international health authorities including the Wolrd Health Organization (WHO) and the United Nations Programme on HIV/AIDS (UNAIDS).PROSPERO registration number CRD420251150712.

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Cite

BibTeXRIS
BibTeX
@article{nkugwa2026impact,
  title = {{Impact of breastfeeding beyond 12 months on HIV transmission, mortality and morbidity among HIV-exposed uninfected infants in sub-Saharan Africa: a protocol for a systematic review and meta-analysis}},
  author = {Juliet Asio Nkugwa and Nicolette Nabukeera-Barungi and Joseph Rujumba and Erick Jacob Okek and Phoebe Namukanja Mayambala Monalisa and Eleanor Namusoke Magongo and Seth Inzaule and Bernard Kikaire},
  journal = {BMJ Open},
  year = {2026},
  month = nov,
  doi = {10.1136/bmjopen-2025-112447},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-112447},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Impact of breastfeeding beyond 12 months on HIV transmission, mortality and morbidity among HIV-exposed uninfected infants in sub-Saharan Africa: a protocol for a systematic review and meta-analysis
AU  - Juliet Asio Nkugwa
AU  - Nicolette Nabukeera-Barungi
AU  - Joseph Rujumba
AU  - Erick Jacob Okek
AU  - Phoebe Namukanja Mayambala Monalisa
AU  - Eleanor Namusoke Magongo
AU  - Seth Inzaule
AU  - Bernard Kikaire
PY  - 2026
DA  - 2026/11/05
JO  - BMJ Open
DO  - 10.1136/bmjopen-2025-112447
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-112447
AB  - Introduction Globally, over 1.1 million HIV-exposed uninfected (HEU) infants are born annually, predominantly in sub-Saharan Africa (SSA). Despite effective prevention of mother-to-child transmission programmes, HEU infants face disproportionately higher risks of malnutrition, morbidity and mortality compared with HIV-unexposed peers. Uncertainty remains about the optimal duration of breastfeeding in this population. Most SSA national guidelines recommend cessation at 12 months, yet emerging evidence suggests that early cessation may increase malnutrition and mortality risk, particularly in resource-limited settings. No recent systematic review has comprehensively synthesised evidence on the effects of extended breastfeeding beyond 12 months on key health outcomes among HEU infants.Methods and analysis This systematic review will include randomised controlled trials (RCTs), quasi-RCTs and prospective and retrospective cohort studies comparing health outcomes in HEU infants breastfed beyond 12 months versus those breastfed for 12 months or less. Electronic databases to be searched include MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Health Sciences Literature, African Index Medicus and Web of Science, from 1 January 2013 to 31 December 2025. Two independent reviewers will screen studies, extract data and assess risk of bias using the Cochrane Risk of Bias tool and the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tools. The primary outcome is the incidence of postnatal HIV transmission. Secondary outcomes include all-cause infant mortality, nutritional status (stunting, wasting, underweight) and morbidity (pneumonia and diarrhoea). Both pairwise and network meta-analyses will be conducted using random-effects models. Evidence certainty will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Ethics and dissemination This study is a systematic review and meta-analysis of previously published studies and does not involve collection of new data from human participants. As such, ethical approval from an Institutional Review Board or Ethics Committee was not required. Findings will be disseminated through a peer-reviewed publication, conference presentations, policy briefs and stakeholder engagement with national and international health authorities including the Wolrd Health Organization (WHO) and the United Nations Programme on HIV/AIDS (UNAIDS).PROSPERO registration number CRD420251150712.
SN  - 2044-6055
SN  - 2044-6055
ER  -