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1. The Impact of Different CD4 Cell-Count Monitoring and Switching Strategies on Mortality in HIV-Infected African Adults on Antiretroviral Therapy: An Application of Dynamic Marginal Structural Models

Author

Ford, Deborah, Robins, James M, Petersen, Maya L, Gibb, Diana M, Gilks, Charles F, Mugyenyi, Peter, Grosskurth, Heiner, Hakim, James, Katabira, Elly, Babiker, Abdel G, Walker, A Sarah, Grosskurth, H, Munderi, P, Kabuye, G, Nsibambi, D, Kasirye, R, Zalwango, E, Nakazibwe, M, Kikaire, B, Nassuna, G, Massa, R, Fadhiru, K, Namyalo, M, Zalwango, A, Generous, L, Khauka, P, Rutikarayo, N, Nakahima, W, Mugisha, A, Todd, J, Levin, J, Muyingo, S, Ruberantwari, A, Kaleebu, P, Yirrell, D, Ndembi, N, Lyagoba, F, Hughes, P, Aber, M, Lara, A Medina, Foster, S, Amurwon, J, Wakholi, B Nyanzi, Mugyenyi, P, Kityo, C, Ssali, F, Tumukunde, D, Otim, T, Kabanda, J, Musana, H, Akao, J, Kyomugisha, H, Byamukama, A, Sabiiti, J, Komugyena, J, Wavamunno, P, Mukiibi, S, Drasiku, A, Byaruhanga, R, Labeja, O, Katundu, P, Tugume, S, Awio, P, Namazzi, A, Bakeinyaga, GT, Katabira, H, Abaine, D, Tukamushaba, J, Anywar, W, Ojiambo, W, Angweng, E, Murungi, S, Haguma, W, Atwiine, S, Kigozi, J, Latif, A, Hakim, J, Robertson, V, Reid, A, Chidziva, E, Bulaya-Tembo, R, Musoro, G, Taziwa, F, Chimbetete, C, Chakonza, L, Mawora, A, Muvirimi, C, Tinago, G, Svovanapasis, P, Simango, M, Chirema, O, Machingura, J, Mutsai, S, Phiri, M, Bafana, T, Chirara, M, Muchabaiwa, L, Muzambi, M, Katabira, E, and Ronald, A

Subjects
Clinical Research, Clinical Trials and Supportive Activities, HIV/AIDS, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Female, HIV Infections, Humans, Male, Models, Statistical, Uganda, Zimbabwe, Africa, antiretroviral therapy, drug switching, dynamic marginal structural models, HIV, monitoring, DART Trial Team, Mathematical Sciences, Medical and Health Sciences, Epidemiology
Abstract

In Africa, antiretroviral therapy (ART) is delivered with limited laboratory monitoring, often none. In 2003-2004, investigators in the Development of Antiretroviral Therapy in Africa (DART) Trial randomized persons initiating ART in Uganda and Zimbabwe to either laboratory and clinical monitoring (LCM) or clinically driven monitoring (CDM). CD4 cell counts were measured every 12 weeks in both groups but were only returned to treating clinicians for management in the LCM group. Follow-up continued through 2008. In observational analyses, dynamic marginal structural models on pooled randomized groups were used to estimate survival under different monitoring-frequency and clinical/immunological switching strategies. Assumptions included no direct effect of randomized group on mortality or confounders and no unmeasured confounders which influenced treatment switch and mortality or treatment switch and time-dependent covariates. After 48 weeks of first-line ART, 2,946 individuals contributed 11,351 person-years of follow-up, 625 switches, and 179 deaths. The estimated survival probability after a further 240 weeks for post-48-week switch at the first CD4 cell count less than 100 cells/mm(3) or non-Candida World Health Organization stage 4 event (with CD4 count

Published
2015

2. High Rate of HIV Resuppression After Viral Failure on First-line Antiretroviral Therapy in the Absence of Switch to Second-line Therapy

Author

Gupta, R. K., Goodall, R. L., Ranopa, M., Kityo, C., Munderi, P., Lyagoba, F., Mugarura, L., Gilks, C. F., Kaleebu, P., Pillay, D., Grosskurth, H., Kabuye, G., Nsibambi, D., Kasirye, R., Zalwango, E., Nakazibwe, M., Kikaire, B., Nassuna, G., Massa, R., Fadhiru, K., Namyalo, M., Zalwango, A., Generous, L., Khauka, P., Rutikarayo, N., Nakahima, W., Mugisha, A., Todd, J., Levin, J., Muyingo, S., Ruberantwari, A., Yirrell, D., Ndembi, N., Hughes, P., Aber, M., Medina Lara, A., Foster, S., Amurwon, J., Mugyenyi, P., Ssali, F., Tumukunde, D., Otim, T., Kabanda, J., Musana, H., Akao, J., Kyomugisha, H., Byamukama, A., Sabiiti, J., Komugyena, J., Wavamunno, P., Mukiibi, S., Drasiku, A., Byaruhanga, R., Labeja, O., Katundu, P., Tugume, S., Awio, P., Namazzi, A., Bakeinyaga, T. G., Katabira, H., Abaine, D., Tukamushaba, J., Anywar, W., Ojiambo, W., Angweng, E., Murungi, S., Haguma, W., Atwiine, S., Kigozi, J., Latif, A., Hakim, J., Robertson, V., Reid, A., Chidziva, E., Bulaya-Tembo, R., Musoro, G., Taziwa, F., Chimbetete, C., Chakonza, L., Mawora, A., Muvirimi, C., Tinago, G., Svovanapasis, P., Simango, M., Chirema, O., Machingura, J., Mutsai, S., Phiri, M., Bafana, T., Chirara, M., Muchabaiwa, L., Muzambi, M., Katabira, E., Ronald, A., Kambungu, A., Lutwama, F., Nanfuka, A., Walusimbi, J., Nabankema, E., Nalumenya, R., Namuli, T., Kulume, R., Namata, I., Nyachwo, L., Florence, A., Kusiima, A., Lubwama, E., Nairuba, R., Oketta, F., Buluma, E., Waita, R., Ojiambo, H., Sadik, F., Wanyama, J., Nabongo, P., Ochai, R., Muhweezi, D., Gilks, C., Boocock, K., Puddephatt, C., Winogron, D., Bohannon, J., Darbyshire, J., Gibb, M. D., Burke, A., Bray, D., Babiker, A., Walker, S. A., Wilkes, H., Rauchenberger, M., Sheehan, S., Peto, L., Taylor, K., Spyer, M., Ferrier, A., Naidoo, B., Dunn, D., Goodall, R., Nanfuka, R., Mufuka-Kapuya, C., Kapaata, A., Katuramur, M., Magala, R., Magambo, B., Mataruka, K., McCormick, A., Musunga, T., Nabankkema, M., Nkalubo, J., Nkurunziza, P., Parry, C., Nyanzi Wakholi, B., Weller, I., Bahendeka, S., Bassett, M., Chogo Wapakhabulo, A., Gazzard, B., Mapuchere, C., Mugurungi, O., Burke, C., Jones, S., Newland, C., Rahim, S., Rooney, J., Smith, M., Snowden, W., Steens, J.- M., Breckenridge, A., McLaren, A., Hill, C., Matenga, J., Pozniak, A., Serwadda, D., Peto, T., Palfreeman, A., and Borok, M.

Subjects
Anti-HIV Agents, HIV, Viral Load, viral resuppression, Dideoxynucleosides, failure, resistance, Drug Combinations, Lamivudine, Africa, HIV/AIDS, Humans, Nevirapine, Viremia, Zidovudine
Abstract

In a randomized comparison of nevirapine or abacavir with zidovudine plus lamivudine, routine viral load monitoring was not performed, yet 27% of individuals with viral failure at week 48 experienced resuppression by week 96 without switching. This supports World Health Organization recommendations that suspected viral failure should trigger adherence counseling and repeat measurement before a treatment switch is considered.

Published
2013

3. [Accepted Manuscript] Implementation of antiretroviral therapy for life in pregnant/breastfeeding HIV+ women (Option B+) alongside rollout and changing guidelines for ART initiation in rural Zimbabwe: the Lablite Project experience

Author

Ford, D., Muzambi, M., Nkhata, M.J., Abongomera, G., Joseph, S., Ndlovu, M., Mabugu, T., Grundy, C., Chan, A.K., Cataldo, F., Kityo, C., Seeley, J., Katabira, E., Gilks, C.F., Reid, A., Hakim, J., Gibb, D.M., and Lablite Team, .

Abstract

Life-long ART for pregnant and breastfeeding women (Option B+) was rolled-out in Zimbabwe from 2014 with simultaneous raising of the CD4 treatment-threshold in non-pregnant/breastfeeding adults and children >5 years to 500 cells/mm. \ud \ud Lablite is an implementation project in Zimbabwe, Malawi and Uganda evaluating ART rollout. Routine patient-level data were collected for 6 months prior to and 12 months after Option B+ rollout at a district hospital and three primary care facilities in Zimbabwe (two with outreach ART; one with no ART provision prior to Option B+). \ud \ud Between September 2013-February 2015 there were 1,686 ART initiations in the four facilities; 91% adults and 9% children aged 350 after the CD4-threshold increase. Estimated 12-month retention on ART was 79% (69%-87%) in Option B+ women (significantly lower in younger women, p=0.01), versus 93% (91%-95%) in other adults (difference p

Published
2016

4. Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial

Author

DART Trial Team, Mugyenyi, P, Walker, AS, Hakim, J, Munderi, P, Gibb, DM, Kityo, C, Reid, A, Grosskurth, H, Darbyshire, JH, Ssali, F, Bray, D, Katabira, E, Babiker, AG, Gilks, CF, Kabuye, G, Nsibambi, D, Kasirye, R, Zalwango, E, Nakazibwe, M, Kikaire, B, Nassuna, G, Massa, R, Fadhiru, K, Namyalo, M, Zalwango, A, Generous, L, Khauka, P, Rutikarayo, N, Nakahima, W, Mugisha, A, Todd, J, Levin, J, Muyingo, S, Ruberantwari, A, Kaleebu, P, Yirrell, D, Ndembi, N, Lyagoba, F, Hughes, P, Aber, M, Lara, A Medina, Foster, S, Amurwon, J, Wakholi, B Nyanzi, Whitworth, J, Wangati, K, Amuron, B, Kajungu, D, Nakiyingi, J, Omony, W, Tumukunde, D, Otim, T, Kabanda, J, Musana, H, Akao, J, Kyomugisha, H, Byamukama, A, Sabiiti, J, Komugyena, J, Wavamunno, P, Mukiibi, S, Drasiku, A, Byaruhanga, R, Labeja, O, Katundu, P, Tugume, S, Awio, P, Namazzi, A, Bakeinyaga, GT, Katabira, H, Abaine, D, Tukamushaba, J, Anywar, W, Ojiambo, W, Angweng, E, Murungi, S, Haguma, W, Atwiine, S, Kigozi, J, Namale, L, Mukose, A, Mulindwa, G, Atwiine, D, Muhwezi, A, Nimwesiga, E, Barungi, G, Takubwa, J, Mwebesa, D, Kagina, G, Mulindwa, M, Ahimbisibwe, F, Mwesigwa, P, Akuma, S, Zawedde, C, Nyiraguhirwa, D, Tumusiime, C, Bagaya, L, Namara, W, Karungi, J, Kankunda, R, Enzama, R, Latif, A, Robertson, V, Chidziva, E, Bulaya-Tembo, R, Musoro, G, Taziwa, F, Chimbetete, C, Chakonza, L, Mawora, A, Muvirimi, C, Tinago, G, Svovanapasis, P, Simango, M, Chirema, O, Machingura, J, Mutsai, S, Phiri, M, Bafana, T, Chirara, M, Muchabaiwa, L, Muzambi, M, Mutowo, J, Chivhunga, T, Chigwedere, E, Pascoe, M, Warambwa, C, Zengeza, E, Mapinge, F, Makota, S, Jamu, A, Ngorima, N, Chirairo, H, Chitsungo, S, Chimanzi, J, Maweni, C, Warara, R, Matongo, M, Mudzingwa, S, Jangano, M, Moyo, K, Vere, L, Mdege, N, Machingura, I, Ronald, A, Kambungu, A, Lutwama, F, Mambule, I, Nanfuka, A, Walusimbi, J, Nabankema, E, Nalumenya, R, Namuli, T, Kulume, R, Namata, I, Nyachwo, L, Florence, A, Kusiima, A, Lubwama, E, Nairuba, R, Oketta, F, Buluma, E, Waita, R, Ojiambo, H, Sadik, F, Wanyama, J, Nabongo, P, Oyugi, J, Sematala, F, Muganzi, A, Twijukye, C, Byakwaga, H, Ochai, R, Muhweezi, D, Coutinho, A, Etukoit, B, Gilks, C, Boocock, K, Puddephatt, C, Grundy, C, Bohannon, J, Winogron, D, Burke, A, Babiker, A, Wilkes, H, Rauchenberger, M, Sheehan, S, Spencer-Drake, C, Taylor, K, Spyer, M, Ferrier, A, Naidoo, B, Dunn, D, Goodall, R, Peto, L, Nanfuka, R, Mufuka-Kapuya, C, Pillay, D, McCormick, A, Weller, I, Bahendeka, S, Bassett, M, Wapakhabulo, A Chogo, Gazzard, B, Mapuchere, C, Mugurungi, O, Burke, C, Jones, S, Newland, C, Pearce, G, Rahim, S, Rooney, J, Smith, M, Snowden, W, Steens, J-M, Breckenridge, A, McLaren, A, Hill, C, Matenga, J, Pozniak, A, Serwadda, D, Peto, T, Palfreeman, A, and Borok, M

Subjects
Male, Neutrophils, HIV Infections, law.invention, Hemoglobins, Randomized controlled trial, law, Medicine, Urea, HIV-Associated Lipodystrophy Syndrome, Hazard ratio, Lamivudine, Anemia, General Medicine, Middle Aged, Viral Load, Anti-Retroviral Agents, Creatinine, Disease Progression, RNA, Viral, Female, Drug Monitoring, Zidovudine, medicine.drug, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Neutropenia, Adolescent, Organophosphonates, Acquired immunodeficiency syndrome (AIDS), Internal medicine, Fast track — Articles, Humans, Nevirapine, Adverse effect, Tenofovir, Aged, Intention-to-treat analysis, business.industry, Adenine, medicine.disease, Dideoxynucleosides, CD4 Lymphocyte Count, Clinical trial, Clinical research, Immunology, Africa, HIV-1, business
Abstract

BACKGROUND: HIV antiretroviral therapy (ART) is often managed without routine laboratory monitoring in Africa; however, the effect of this approach is unknown. This trial investigated whether routine toxicity and efficacy monitoring of HIV-infected patients receiving ART had an important long-term effect on clinical outcomes in Africa. METHODS: In this open, non-inferiority trial in three centres in Uganda and one in Zimbabwe, 3321 symptomatic, ART-naive, HIV-infected adults with CD4 counts less than 200 cells per microL starting ART were randomly assigned to laboratory and clinical monitoring (LCM; n=1659) or clinically driven monitoring (CDM; n=1662) by a computer-generated list. Haematology, biochemistry, and CD4-cell counts were done every 12 weeks. In the LCM group, results were available to clinicians; in the CDM group, results (apart from CD4-cell count) could be requested if clinically indicated and grade 4 toxicities were available. Participants switched to second-line ART after new or recurrent WHO stage 4 events in both groups, or CD4 count less than 100 cells per microL (LCM only). Co-primary endpoints were new WHO stage 4 HIV events or death, and serious adverse events. Non-inferiority was defined as the upper 95% confidence limit for the hazard ratio (HR) for new WHO stage 4 events or death being no greater than 1.18. Analyses were by intention to treat. This study is registered, number ISRCTN13968779. FINDINGS: Two participants assigned to CDM and three to LCM were excluded from analyses. 5-year survival was 87% (95% CI 85-88) in the CDM group and 90% (88-91) in the LCM group, and 122 (7%) and 112 (7%) participants, respectively, were lost to follow-up over median 4.9 years' follow-up. 459 (28%) participants receiving CDM versus 356 (21%) LCM had a new WHO stage 4 event or died (6.94 [95% CI 6.33-7.60] vs 5.24 [4.72-5.81] per 100 person-years; absolute difference 1.70 per 100 person-years [0.87-2.54]; HR 1.31 [1.14-1.51]; p=0.0001). Differences in disease progression occurred from the third year on ART, whereas higher rates of switch to second-line treatment occurred in LCM from the second year. 283 (17%) participants receiving CDM versus 260 (16%) LCM had a new serious adverse event (HR 1.12 [0.94-1.32]; p=0.19), with anaemia the most common (76 vs 61 cases). INTERPRETATION: ART can be delivered safely without routine laboratory monitoring for toxic effects, but differences in disease progression suggest a role for monitoring of CD4-cell count from the second year of ART to guide the switch to second-line treatment. FUNDING: UK Medical Research Council, the UK Department for International Development, the Rockefeller Foundation, GlaxoSmithKline, Gilead Sciences, Boehringer-Ingelheim, and Abbott Laboratories.

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5. Impact of second-line antiretroviral regimens on lipid profiles in an African setting: The DART trial sub-study

Author

Gomo, Z. A. R., Hakim, J. G., Walker, S. A., Tinago, W., Mandozana, G., Kityo, C., Munderi, P., Katabira, E., Reid, A., Gibb, D. M., Gilks, C. F., Grosskurth, H., Kabuye, G., Nsibambi, D., Kasirye, R., Zalwango, E., Nakazibwe, M., Kikaire, B., Nassuna, G., Massa, R., Fadhiru, K., Namyalo, M., Zalwango, A., Generous, L., Khauka, P., Rutikarayo, N., Nakahima, W., Mugisha, A., Todd, J., Levin, J., Muyingo, S., Ruberantwari, A., Kaleebu, P., Yirrell, D., Ndembi, N., Lyagoba, F., Hughes, P., Aber, M., Lara, A. M., Medina, A., Foster, S., Amurwon, J., Wakholi, B. N., Nyanzi, B., Wangati, K., Amuron, B., Kajungu, D., Nakiyingi, J., Omony, W., Mugyenyi, P., Ssali, F., Tumukunde, D., Otim, T., Kabanda, J., Musana, H., Akao, J., Kyomugisha, H., Byamukama, A., Sabiiti, J., Komugyena, J., Wavamunno, P., Mukiibi, S., Drasiku, A., Byaruhanga, R., Labeja, O., Katundu, P., Tugume, S., Awio, P., Namazzi, A., Bakeinyaga, G. T., Abaine, D., Tukamushaba, J., Anywar, W., Ojiambo, W., Angweng, E., Murungi, S., Haguma, W., Atwiine, S., Kigozi, J., Namale, L., Mukose, A., Mulindwa, G., Atwiine, D., Muhwezi, A., Nimwesiga, E., Barungi, G., Takubwa, J., Mwebesa, D., Kagina, G., Mulindwa, M., Ahimbisibwe, F., Mwesigwa, P., Akuma, S., Zawedde, C., Nyiraguhirwa, D., Tumusiime, C., Bagaya, L., Namara, W., Karungi, J., Kankunda, R., Enzama, R., Latif, A., Robertson, V., Chidziva, E., Bulaya-Tembo, R., Musoro, G., Taziwa, F., Chimbetete, C., Chakonza, L., Mawora, A., Muvirimi, C., Svovanapasis, P., Simango, M., Chirema, O., Machingura, J., Mutsai, S., Phiri, M., Bafana, T., Chirara, M., Muchabaiwa, L., Muzambi, M., Chigwedere, E., Pascoe, M., Warambwa, C., Zengeza, E., Mapinge, F., Makota, S., Jamu, A., Ngorima, N., Chirairo, H., Chitsungo, S., Chimanzi, J., Maweni, C., Warara, R., Matongo, M., Mudzingwa, S., Jangano, M., Moyo, K., Vere, L., Machingura, I., Ronald, A., Kambungu, A., Lutwama, F., Mambule, I., Nanfuka, A., Walusimbi, J., Nabankema, E., Nalumenya, R., Namuli, T., Kulume, R., Namata, I., Nyachwo, L., Florence, A., Kusiima, A., Lubwama, E., Nairuba, R., Oketta, F., Buluma, E., Waita, R., Ojiambo, H., Sadik, F., Wanyama, J., Nabongo, P., Oyugi, J., Sematala, F., Muganzi, A., Twijukye, C., Byakwaga, H., Ochai, R., Muhweezi, D., Coutinho, A., Etukoit, B., Boocock, K., Puddephatt, C., Grundy, C., Bohannon, J., Winogron, D., Darbyshire, J., Burke, A., Bray, D., Babiker, A., Wilkes, H., Rauchenberger, M., Sheehan, S., Spencer-Drake, C., Taylor, K., Spyer, M., Ferrier, A., Naidoo, B., Dunn, D., Ruth Goodall, Nanfuka, R., Mufuka-Kapuya, C., Pillay, D., Goodall, R., Kapaata, A., Katuramur, M., Magala, R., Magambo, B., Mataruka, K., Mccormick, A., Mugarura, L., Musunga, T., Nabankkema, M., Nkalubo, J., Nkurunziza, P., Parry, C., Weller, I., Bahendeka, S., Bassett, M., Chogo Wapakhabulo, A., Gazzard, B., Mapuchere, C., Mugurungi, O., Burke, C., Distel, M., Jones, S., Loeliger, E., Naidoo, P., Newland, C., Pearce, G., Rahim, S., Rooney, J., Smith, M., Snowden, W., Steens, J. -M, Breckenridge, A., Mclaren, A., Hill, C., Matenga, J., Pozniak, A., Serwadda, D., Peto, T., Palfreeman, A., and Borok, M.

6. Implementation of Antiretroviral Therapy for Life in Pregnant/Breastfeeding HIV+ Women (Option B+) Alongside Rollout and Changing Guidelines for ART Initiation in Rural Zimbabwe: The Lablite Project Experience.

Author

Ford D, Muzambi M, Nkhata MJ, Abongomera G, Joseph S, Ndlovu M, Mabugu T, Grundy C, Chan AK, Cataldo F, Kityo C, Seeley J, Katabira E, Gilks CF, Reid A, Hakim J, and Gibb DM

Subjects
Adolescent, Adult, Child, Child, Preschool, Female, Guideline Adherence, Humans, Infant, Male, Middle Aged, Pregnancy, Rural Population, World Health Organization, Zimbabwe, Anti-Retroviral Agents administration & dosage, Antiretroviral Therapy, Highly Active methods, Breast Feeding, HIV Infections drug therapy, Postpartum Period, Pregnancy Complications, Infectious drug therapy
Abstract

Background: Lifelong antiretroviral therapy (ART) for pregnant and breastfeeding women (Option B+) was rolled out in Zimbabwe from 2014, with simultaneous raising of the CD4 treatment threshold to 500 cells per cubic millimeter in nonpregnant/breastfeeding adults and children 5 years and over., Methods: Lablite is an implementation project in Zimbabwe, Malawi, and Uganda evaluating ART rollout. Routine patient-level data were collected for 6 months before and 12 months after Option B+ rollout at a district hospital and 3 primary care facilities in Zimbabwe (2 with outreach ART and 1 with no ART provision before Option B+)., Results: Between September 2013 and February 2015, there were 1686 ART initiations in the 4 facilities: 91% adults and 9% children younger than 15 years. In the 3 facilities with established ART, initiations rose from 300 during 6 months before Option B+ to 869 (2.9-fold) and 463 (1.5-fold), respectively, 0-6 months and 6-12 months after Option B+. Post-Option B+, an estimated 43% of pregnant/breastfeeding women needed ART for their own health, based on World Health Organization stage 3/4 or CD4 ≤350 per cubic millimeter (64% for CD4 ≤500). Seventy-four men (22%) and 123 nonpregnant/breastfeeding women (34%) initiated ART with CD4 >350 after the CD4 threshold increase. Estimated 12-month retention on ART was 79% (69%-87%) in Option B+ women (significantly lower in younger women, P = 0.01) versus 93% (91%-95%) in other adults (difference P < 0.001)., Conclusions: There were increased ART initiations in all patient groups after implementation of World Health Organization 2013 guidelines. Retention of Option B+ women was poorer than retention of other adults; younger women require attention because they are more likely to disengage from care.

Published
2017
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7. Shifting human resources for health in the context of ART provision: qualitative and quantitative findings from the Lablite baseline study.

Author

Nkhata MJ, Muzambi M, Ford D, Chan AK, Abongomera G, Namata H, Mambule I, South A, Revill P, Grundy C, Mabugu T, Chiwaula L, Hakim J, Kityo C, Reid A, Katabira E, Sodhi S, Gilks CF, Gibb DM, Seeley J, and Cataldo F

Subjects
Cross-Sectional Studies, Focus Groups, Health Care Surveys, Humans, Malawi, Politics, Qualitative Research, Rural Health Services organization & administration, Uganda, Workforce, Zimbabwe, Ambulatory Care Facilities organization & administration, Anti-Retroviral Agents therapeutic use, Attitude of Health Personnel, HIV Infections drug therapy, Health Personnel education, Job Satisfaction, Primary Health Care organization & administration, Workload
Abstract

Background: Lablite is an implementation project supporting and studying decentralized antiretroviral therapy (ART) rollout to rural communities in Malawi, Uganda and Zimbabwe. Task shifting is one of the strategies to deal with shortage of health care workers (HCWs) in ART provision. Evaluating Human Resources for Health (HRH) optimization is essential for ensuring access to ART. The Lablite project started with a baseline survey whose aim was to describe and compare national and intercountry delivery of ART services including training, use of laboratories and clinical care., Methods: A cross-sectional survey was conducted between October 2011 and August 2012 in a sample of 81 health facilities representing different regions, facility levels and experience of ART provision in Malawi, Uganda and Zimbabwe. Using a questionnaire, data were collected on facility characteristics, human resources and service provision. Thirty three (33) focus group discussions were conducted with HCWs in a subset of facilities in Malawi and Zimbabwe., Results: The survey results showed that in Malawi and Uganda, primary care facilities were run by non-physician clinical officers/medical assistants while in Zimbabwe, they were run by nurses/midwives. Across the three countries, turnover of staff was high especially among nurses. Between 10 and 20% of the facilities had at least one clinical officer/medical assistant leave in the 3 months prior to the study. Qualitative results show that HCWs in ART and non-ART facilities perceived a shortage of staff for all services, even prior to the introduction of ART provision. HCWs perceived the introduction of ART as having increased workload. In Malawi, the number of people on ART and hence the workload for HCWs has further increased following the introduction of Option B+ (ART initiation and life-long treatment for HIV positive pregnant and lactating women), resulting in extended working times and concerns that the quality of services have been affected. For some HCWs, perceived low salaries, extended working schedules, lack of training opportunities and inadequate infrastructure for service provision were linked to low job satisfaction and motivation., Conclusions: ART has been decentralized to lower level facilities in the context of an ongoing HRH crisis and staff shortage, which may compromise the provision of high-quality ART services. Task shifting interventions need adequate resources, relevant training opportunities, and innovative strategies to optimize the operationalization of new WHO treatment guidelines which continue to expand the number of people eligible for ART.

Published
2016
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8. The Lablite project: a cross-sectional mapping survey of decentralized HIV service provision in Malawi, Uganda and Zimbabwe.

Author

Chan AK, Ford D, Namata H, Muzambi M, Nkhata MJ, Abongomera G, Mambule I, South A, Revill P, Grundy C, Mabugu T, Chiwaula L, Cataldo F, Hakim J, Seeley J, Kityo C, Reid A, Katabira E, Sodhi S, Gilks CF, and Gibb DM

Subjects
Adolescent, Adult, Cross-Sectional Studies, HIV Infections diagnosis, Health Care Surveys, Humans, Malawi, Middle Aged, Reagent Kits, Diagnostic supply & distribution, Surveys and Questionnaires, Uganda, Viral Load, Young Adult, Zimbabwe, Anti-Retroviral Agents therapeutic use, HIV Infections drug therapy, Primary Health Care organization & administration
Abstract

Background: In sub-Saharan Africa antiretroviral therapy (ART) is being decentralized from tertiary/secondary care facilities to primary care. The Lablite project supports effective decentralization in 3 countries. It began with a cross-sectional survey to describe HIV and ART services., Methods: 81 purposively sampled health facilities in Malawi, Uganda and Zimbabwe were surveyed., Results: The lowest level primary health centres comprised 16/20, 21/39 and 16/22 facilities included in Malawi, Uganda and Zimbabwe respectively. In Malawi and Uganda most primary health facilities had at least 1 medical assistant/clinical officer, with average 2.5 and 4 nurses/midwives for median catchment populations of 29,275 and 9,000 respectively. Primary health facilities in Zimbabwe were run by nurses/midwives, with average 6 for a median catchment population of 8,616. All primary health facilities provided HIV testing and counselling, 50/53 (94%) cotrimoxazole preventive therapy (CPT), 52/53 (98%) prevention of mother-to-child transmission of HIV (PMTCT) and 30/53 (57%) ART management (1/30 post ART-initiation follow-up only). All secondary and tertiary-level facilities provided HIV and ART services. In total, 58/81 had ART provision. Stock-outs during the 3 months prior to survey occurred across facility levels for HIV test-kits in 55%, 26% and 9% facilities in Malawi, Uganda and Zimbabwe respectively; for CPT in 58%, 32% and 9% and for PMTCT drugs in 26%, 10% and 0% of facilities (excluding facilities where patients were referred out for either drug). Across all countries, in facilities with ART stored on-site, adult ART stock-outs were reported in 3/44 (7%) facilities compared with 10/43 (23%) facility stock-outs of paediatric ART. Laboratory services at primary health facilities were limited: CD4 was used for ART initiation in 4/9, 5/6 and 13/14 in Malawi, Uganda and Zimbabwe respectively, but frequently only in selected patients. Routine viral load monitoring was not used; 6/58 (10%) facilities with ART provision accessed centralised viral loads for selected patients., Conclusions: Although coverage of HIV testing, PMTCT and cotrimoxazole prophylaxis was high in all countries, decentralization of ART services was variable and incomplete. Challenges of staffing and stock management were evident. Laboratory testing for toxicity and treatment effectiveness monitoring was not available in most primary level facilities.

Published
2014
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