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Background: Complete follow up is an essential component of observational cohorts irrespective of the type of disease. Objectives: To describe five years follow up of mother and child pairs on a PMTCT program, highlighting loss to follow up (LTFU) and mortality (attrition). Study Design: A cohort of pregnant women was enrolled from the national PMTCT program at 36 weeks gestational age attending three peri urban clinics around Harare offering maternal and child health services. Mother-infant pairs were followed up from birth and twice yearly for five years. Results: A total of 479 HIV infected and 571 HIV negative pregnant women were enrolled, 445(92.9%) and 495(86.6%) were followed up whereas 14(3.0%) and 3(0.5%) died in the 1st year respectively; RR (95%CI) 5.3(1.5-18.7). At five years 227(56.7%) HIV infected and 239(41.0%) HIV negative mothers turned up, whereas mortality rates were 34 and 7 per 100 person years respectively. Birth information was recorded for 401(83.7%) HIV exposed and 441(77.2%) unexposed infants, 247(51.6%) and 232(40.6) turned up in the first year whilst mortality was 58(12.9%) and 22(4.4%) respectively, RR (95%CI) 3.2(2.0-5.4). At five years 210(57.5%) HIV exposed and 239(44.3%) unexposed infants were seen, whilst mortality rates were 53 per 1000 and 15 per 1 000 person years respectively. Mortality rate for HIV infected children was 112 compared to 21 per 1 000 person years for the exposed but uninfected. Conclusion: HIV infected mothers and their children succumbed to mortality whereas the HIV negatives were LTFU. Mortality rates and LTFU are high within PMTCT program.© Kurewa et al.
A cohort of mother and child pairs was recruited from the national PMTCT program and followed up for five years. Three peri urban clinics around Harare the capital city of Zimbabwe, namely; Epworth; St Marys and Seke North. These are primary health care settings offering maternal and child health services. Pregnant women booked at the respective Antenatal Clinics (ANC), who have gone through the national PMTCT (VCT) were followed up together with their index children from birth up to 5 years. Pregnant women from 36 weeks of gestation coming through the national PMTCT program. Pregnant women with known complications and who not had to deliver at a primary health care setting were excluded. The intention was to recruit 300 HIV positive and 600 HIV negative pregnant women allowing for 10% LFU. ‘EPISTAT’ program was used to calculate the sample size. A questionnaire sourcing socio demographic, life styles and living conditions, obstetric and reproductive history, contraception and knowledge of STI/HIV signs and symptoms was administered to the women at enrolment. In addition to routine antenatal care women were screened for other sexually transmitted infections and reproductive tract infections (RTI)s. Those found infected were treated and encouraged to inform their sexual partners to come for treatment which was given for free. A locator form was used to document the physical and postal address of the mother or care giver and next of kin details were obtained for those who consented to home visits, where available contact telephone numbers were obtained for follow up purposes. Trained counselors residing in the same community were responsible for the follow up of those participants who missed their scheduled visits. All transport costs were reimbursed, whilst all clinical care expenses related to any clinical event were supported by the project. At birth HIV infected mothers received a single 200-mg Nevirapine dose at the onset of labor, and their infants received a single 1-2 mg Nevirapine dose within 72 hours of delivery (sdNVP). Nevirapine was provided by the government of Zimbabwe under the national PMTCT program. Support groups were introduced during the second year of follow up where women met clinician once every week. At each study clinic women were encouraged to form one group for both HIV infected and negative women. They chose a convenient day where they would meet at a specified time for up to 2 hours and a coordinator amongst themselves to act as a link person between them and the researchers. Health education talks were given to the women interacting with the research nurses, counselors, psychologist and sociologist to respond to their concerns in a participatory manner. Women were also given an opportunity to suggest topics which they felt relevant to their day to day lives. They were encouraged to bring their spouses and significant members like mothers’ in law or any caregiver for the index child where the mother had been lost. Note: Enrolment was done during the time when prolonged ARVs were not readily available in the country except for the sdNVP, whereas CD4 counts were not routinely done at government institutions due to prohibitive costs. However over the follow up period when they became available and affordable the project facilitated referral for the HIV infected and exposed children to access both CD4 counts and ARVs when indicated from the government opportunistic clinics (OI). This was conducted within the same study clinics where maternal and child health services are provided. A separate room was provided for the study procedures throughout the follow up period. Mothers were followed up according to their expected date of term (EDT) to ascertain site and mode of delivery and for the HIV infected to ensure provision of NVP. A birth form was used to document birth information; onset of labour, time of rupture of membranes, duration of labor, collection of venous blood and for the HIV infected women, time of ingesting Nevirapine tablet. All mothers and their infants were followed up for 6 weeks, four and nine months and every six months thereafter for five years. Mother and child health status was assessed and documented in the appropriate form according to the age after birth. Infant feeding practices were assessed and documented at each visit. HIV infected mothers and their exposed infants were given prophylactic cotrimoxazole. For the exposed infants cotrimoxazole would be stopped if they tested negative for HIV. HIV infected mothers had a general physical and gynaecological examination performed together with CD4 counts that were assessed every six months. Those with a low CD4 count (<less than 200 mm/l would be send for a chest x- ray, blood chemistry; liver function tests (LFTs), Urea and electrolytes (U & Es and full blood count (FBC) for easy access and referral to the government opportunistic infection (OI) clinics for ARV therapy. Outcome information was when the study participants were considered to be alive; they turned up for their scheduled visit, they could be contacted over the phone, could be seen at home or if a spouse or close relative, or care giver of the child could confirm that they were alive during the period under observation. They were considered deceased if a spouse, close relative, landlord or neighbor seen at their house or nearby confirmed verbally or medical records that confirmed their death. In the case where the visit was unsuccessful, they were not proven as deceased or alive and follow up visits would have been repeated for unspecified times and all channels of contact exhausted. They would then be considered as LFU. Follow up of the commenced from birth for both HIV exposed and unexposed neonates was carried out. Birth information was recorded in an infant birth form by the midwife regarding status of the neonate at birth; alive or still born, Apgar score, physical examination including anthropometrical measurements and collection of a cord blood sample for the HIV exposed infants. Thereafter venous blood was collected at each follow up visit; 6 weeks, 4 and 9 months for HIV- DNA PCR test using cell pellets by prototype Roche Amplicor version 1.5 qualitative PCR assay (Roche Diagnostic Systems). At six weeks cotrimoxazole suspension was given to all HIV exposed infants until they were screened and found negative. At each visit a health status was documented in the appropriate form according to age at visit after a complete physical examination of the infant together with anthropometric measurements and feeding practices. A Bailey Infant Neurological development test (BINS) was performed from 3 to 24 months. Thereafter the children continued to have a general health status assessment every six months performed by the study paediatrician. HIV exposed infants were screened for HIV one month after cessation of breastfeeding and from 15 months onwards. HIV infected infants had a full blood count test (FBC), blood chemistry tests and CD4 counts every six months. Where the infants indicated were referred to OI clinics to be commenced on ARVs. Infants were classified at birth according to maternal HIV status that was determined at approximately 36 weeks of gestation and this status was maintained for the analysis of this paper. At each scheduled visit information was sourced from the mother or care giver about the health status of the infant. Those who did not turn up for the scheduled visit were followed up to ascertain reason for defaulting. If found they would be rescheduled for the next visit. An infant was considered as LTFU if he was not brought in for the stipulated visit and not declared as deceased by either the parents or caregiver. The infants were considered dead through evidence from verbal autopsy for the baby given by either the mother or care giver or when available clinical records were analyzed to ascertain cause of death. Attrition, (defined as the total sum of those who were LTFU and those that died) was assessed at each scheduled visit over the five years. Both the Medical Research Council of Zimbabwe and the Ethical Review Committee in Norway approved the study. Mothers who agreed to participate gave an informed written consent that covered themselves and their index babies to be followed up from birth. Data were entered and analyzed using SPSS and STATA Version 9 from StataCorp Texas USA. All mothers enrolled in pregnancy were assessed whilst all live born infants were available for analysis. In the case of multiple births only the first born was included to avoid mixing up of the children. Baseline characteristics were compared using Pearson X2 test for categorical variables and independent sample student’s t test for continuous variables. Follow up of mothers and infants reflecting on those seen, LFU and deceased at each scheduled visit from birth to 5 years is demonstrated by a flow diagram (Figs. 11, 22). Mothers follow Up over 5 years. Infants follow up over 5 years. Scheduled visits were combined from birth up to one year to summarize those ever seen and those who were LTFU and the ones that died as outcome information. Risk ratios with their 95% CI of dying or being lost to follow up were estimated over the 1st year and at five years using maternal HIV status at enrolment. Follow up time was measured in months from enrolment up to 60 months ending at the earliest month of death and ending at the last follow up visit, date of last contact. The statistical significance threshold was 5%, whilst all reported p values were 2 sided.
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