HIV DNA PCR Test Research Articles

Rapid antiretroviral therapy initiation following rollout of point-of-care early infant diagnosis testing, Uganda, 2018–2021

BackgroundUganda Ministry of Health (MOH) recommends a first HIV DNA-PCR test at 4–6 weeks for early infant diagnosis (EID) of HIV-exposed infants (HEI) and immediate return of results. WHO recommends initiating antiretroviral therapy (ART) ≤ 7 days from HIV diagnosis. In 2019, MOH introduced point-of-care (POC) whole-blood EID testing in 33 health facilities and scaled up to 130 facilities in 2020. We assessed results turnaround time and ART linkage pre-POC and during POC testing.MethodsWe evaluated EID register data for HEI at 10 health facilities with POC and EID testing volume of ≥ 12 infants/month from 2018 to 2021. We abstracted data for 12 months before and after POC testing rollout and compared time to sample collection, results receipt, and ART initiation between periods using medians, Wilcoxon, and log-rank tests.ResultsData for 4.004 HEI were abstracted, of which 1.685 (42%) were from the pre-POC period and 2.319 (58%) were from the period during POC; 3.773 (94%) had a first EID test (pre-POC: 1.649 [44%]; during POC: 2.124 [56%]). Median age at sample collection was 44 (IQR 38–51) days pre-POC and 42 (IQR 33–50) days during POC (p < 0.001). Among 3.773 HEI tested, 3.678 (97%) had test results. HIV-positive infants’ (n = 69) median age at sample collection was 94 (IQR 43–124) days pre-POC and 125 (IQR 74–206) days during POC (p = 0.04). HIV positivity rate was 1.6% (27/1.617) pre-POC and 2.0% (42/2.061) during POC (p = 0.43). For all infants, median days from sample collection to results receipt by infants’ caregivers was 28 (IQR 14–52) pre-POC and 1 (IQR 0–25) during POC (p < 0.001); among HIV-positive infants, median days were 23 (IQR 7–30) pre-POC and 0 (0–3) during POC (p < 0.001). Pre-POC, 4% (1/23) HIV-positive infants started ART on the sample collection day compared to 33% (12/37) during POC (p < 0.001); ART linkage ≤ 7 days from HIV diagnosis was 74% (17/23) pre-POC and 95% (35/37) during POC (p < 0.001).ConclusionPOC testing improved EID results turnaround time and ART initiation for HIV-positive infants. While POC testing expansion could further improve ART linkage and loss to follow-up, there is need to explore barriers around same-day ART initiation for infants receiving POC testing.

HIV prevalence among children admitted with severe acute malnutrition and associated factors with mother-to-child HIV transmission at Mulago Hospital, Uganda: A mixed methods study.

Despite global efforts to eliminate mother-to-child-transmission of HIV (MTCT), many children continue to become infected. We determined the prevalence of HIV among children with severe acute malnutrition (SAM) and that of their mothers, at admission to Mwanamugimu Nutrition Unit, Mulago Hospital, Uganda. We also assessed child factors associated with HIV-infection, and explored factors leading to HIV-infection among a subset of the mother-child dyads that tested positive. We conducted a cross-sectional evaluation within the REDMOTHIV (Reduce mortality in HIV) clinical trial that investigated strategies to reduce mortality among HIV-infected and HIV-exposed children admitted with SAM at the Nutrition Unit. From June 2021 to December 2022, we consecutively tested children aged 1 month to 5 years with SAM for HIV, and the mothers who were available, using rapid antibody testing upon admission to the unit. HIV-antibody positive children under 18 months of age had a confirmatory HIV-DNA PCR test done. In-depth interviews (IDIs) were conducted with mothers of HIV positive dyads, to explore the individual, relationship, social and structural factors associated with MTCT, until data saturation. Quantitative data was analyzed using descriptive statistics and logistic regression in STATAv14, while a content thematic approach was used to analyze qualitative data. Of 797 children tested, 463(58.1%) were male and 630(79.1%) were ≤18months of age; 76 (9.5%) tested positive. Of 709 mothers, median (IQR) age 26 (22, 30) years, 188(26.5%) were HIV positive. Sixty six of the 188 mother-infant pairs with HIV exposure tested positive for HIV, an MTCT rate of 35.1% (66/188). Child age >18 months was marginally associated with HIV-infection (crude OR = 1.87,95% CI: 1.11-3.12, p-value = 0.02; adjusted OR = 1.72, 95% CI: 0.96, 3.09, p-value = 0.068). The IDIs from 16 mothers revealed associated factors with HIV transmission at multiple levels. Individual level factors: inadequate information regarding prevention of MTCT(PMTCT), limited perception of HIV risk, and fear of antiretroviral drugs (ARVs). Relationship level factors: lack of family support and unfaithfulness (infidelity) among sexual partners. Health facility level factors: negative attitude of health workers and missed opportunities for HIV testing. Community level factors: poverty and health service disruptions due to the COVID-19 pandemic. In this era of universal antiretroviral therapy for PMTCT, a 10% HIV prevalence among severely malnourished children is substantially high. To eliminate vertical HIV transmission, more efforts are needed to address challenges mothers living with HIV face intrinsically and within their families, communities and at health facilities.

Molecular confirmation of HIV-1 and HIV-2 coinfections among initially serologically dually-reactive samples from patients living in West Africa.

This study aimed to confirm the co-infection with HIV-1 and HIV-2, among West African patients using in-house HIV type/group enzyme-immuno assays and molecular diagnosis. A cross-sectional survey was conducted from April 2016 to October 2017 in the biggest HIV clinics of Côte d'Ivoire and Burkina Faso. A first serological confirmation was done in the referral laboratory using an in-house, indirect immuno-enzymatic essay allowing the qualitative detection of both HIV-1 and HIV-2 antibodies. In order to separately detect anti-HIV-1 and anti-HIV-2 antibodies, a type/group specific enzyme-immuno assay (HIV-GSEIA) was used. To confirm the co-infections, HIV-1 and HIV-2 DNA-qualitative PCR assays were performed. A total of 91 patients were enrolled in the study and provided blood sample for HIV type confirmatory testing including 13 (14.3%) HIV-2 mono-reactive and 78 (85.7%) HIV-1/HIV-2 dually-reactive based on the HIV testing National Algorithms. The first serological ELISA confirmatory test performed showed that 80 (78.9%) of the 91 participants were dually-reactive. The HIV-GSEIA performed on these 80 serum samples retrieve one 61 HIV-1/HIV-2 dually-reactive samples. HIV-1 and HIV-2 DNA PCR were performed on 54 of the 61 HIV-1/HIV-2 dually-reactive samples and 46 out of 61 (75.4%) samples were found HIV-1/HIV-2 coinfected. The contribution of type/group specific enzyme-immuno assay to accurately identify HIV-1/HIV-2 coinfections remain suboptimal, emphasizing the need for molecular diagnosis platforms in West Africa, to avail HIV DNA PCR test for the confirmation of HIV-1/HIV-2 co-infections.

Vertical HIV transmission within 18 months post partum among women on lifelong antiretroviral therapy for HIV in Dar es Salaam, Tanzania: a prospective cohort study

The UNAIDS estimate of vertical HIV transmission in Tanzania is high (11%), despite 84% uptake of antiretroviral therapy (ART) among pregnant women with HIV. We aimed to evaluate vertical transmission and its determinants by 18 months post partum among women on lifelong ART in routine health-care settings in Tanzania. We conducted a prospective cohort study in 226 health facitilies across Dar-es-Salaam, Tanzania. Eligible participants were pregnant women of any age with HIV, and later their infants, who enrolled in routine health-care services for the prevention of vertical transmission. We prospectively followed up mother-infant pairs at routine monthly visits until 18 months post partum and extracted data from the care and treatment clinic (CTC2) database, a national electronic database that stores patient-level HIV care and treatment clinic data. The primary outcome was time from birth to HIV diagnosis, defined as a positive infant HIV DNA PCR or antibody test from age 18 months. We used the Kaplan-Meier method to estimate cumulative risk of vertical transmission by 18 months post partum and Cox proportional hazards regression with shared frailties to account for potential clustering in health facilities to evaluate predictors of transmission. Between Jan 1, 2015, and Dec 31, 2017, 22 930 pregnant women with HIV (median age 30 years, IQR 25-34) enrolled on a care programme. After excluding 9140 (39·9%) women and 539 (2·4%) infants with missing outcome data, 13 251 (59·0%) mother-infant pairs were analysed, of whom 6072 (45·8%) women were already on ART before pregnancy. By 18 months post partum, 159 (1·2%) of 13 251 infants were diagnosed with HIV, equivalent to a risk of vertical transmission of 1·4% (95% CI 1·2-1·6). In the complete case analysis, the rates of vertical transmission were higher among women who enrolled in the third trimester of pregnancy than among those who enrolled in the first trimester (adjusted hazard ratio 3·01, 95% CI 1·59-5·70; p=0·0003), among women with advanced HIV disease than among those with early-stage disease (1·89, 1·22-2·93; p=0·0046), and among women who were on a second-line ART regimen than among those on a first-line regimen (3·58, 1·08-11·82; p=0·037). By contrast, the rate of vertical transmission was lower among women who were already on ART at enrolment than among those starting ART at enrolment (0·39, 0·25-0·60; p<0·0001) as well as among women in high-volume clinics than among those in low-volume clinics (0·46 (0·24-0·90; p<0·0097). Provision of ART for life (WHO's option B+ recommendation) has reduced the risk of vertical transmission to less than 2% among pregnant women with HIV in routine care settings in urban Tanzania. There is still a need to improve timely HIV diagnosis and ART uptake, and to optimise follow-up for the prevention of vertical transmission and the uptake of infant HIV testing. Swedish International Development Cooperation Agency.

Early infant diagnosis of HIV infection at the John F. Kennedy Medical Center, Monrovia, Liberia

Background: Vertical transmission accounts for majority of new HIV infections among children worldwide. Ninety percent of HIV-positive children reside in Sub- Saharan Africa with their infection predominantly acquired via vertical transmission. In 2004, the vertical transmission rate of HIV in Africa was estimated at 25 − 40% but, remarkably, the rate has significantly decreased to less than 5% in most African countries following implementation and expansion of prevention of MTCT (PMTCT) programs. Objective: To determine the rate of and factors associated with vertical transmission of HIV among attendees of early infant diagnosis (EID) program of an academic and community-based tertiary facility in Liberia. Design: A retrospective cross-sectional analysis. Methods: A retrospective review of medical records of babies seen at Pediatric Unit of Infectious Disease Clinic of John F Kennedy Medical Center (JFKMC) in Monrovia, Liberia between January 1, 2016 and December 31, 2020. All subjects were children born to HIV-positive mothers and who had HIV DNA PCR testing performed between the ages of 6 weeks and 6 months. Children who suffered early neonatal death and those who did not undergo PCR testing were excluded. Demographics of mother to child pairs as well as factors known to influence vertical transmission of HIV such as partial (15.8%) or full (84.2%) participation in prevention of MTCT (PMTCT) programs, mode of delivery, breastfeeding and utilization of post-exposure prophylaxis were collected and assessed. Binomial logistic regression analyses were used to assess factors associated with vertical transmission. Results: During the study timeframe, 284 children had a HIV DNA PCR test with a male:female ratio − 1.3:1. Sixteen tested positive (conducted at a mean of 155 days post birth) giving a vertical transmission rate of 5.6%. For 239 mothers (84.2%) who had full PMTCT, 1.3% of their children tested positive, while for 45 mothers (15.8%) who had partial PMTCT, 28.8% of their children being positive. Two hundred and seventy six children (97%) had exclusive breastfeeding, 13 of whom tested positive while 2 children who were mixed fed tested positive. Children who had Nevirapine vs no prophylaxis (OR = 1.89[95% CI 1.16 − 2.96]), were delivered via caesarian section vs vaginal delivery (OR= 2.26[95% CI 1.92 − 4.12].) and full versus partial participation in PMTCT programs (OR = 4.02[95% CI 2.06 − 4.13] were more likely to have negative HIV test. Conclusion: Vertical transmission rate was found to be high in Liberia and may be driven by suboptimal PMTCT program participation including post-exposure prophylaxis for infants. Therefore, strategies to scale up and improve uptake of PMTCT services are needed to mitigate the burden of HIV among children.

The effect of a Mentor Mothers program on prevention of vertical transmission of HIV outcomes in Zambézia Province, Mozambique: a retrospective interrupted time series analysis.

IntroductionMentor Mothers (MM) provide peer support to pregnant and postpartum women living with HIV (PPWH) and their infants with perinatal HIV exposure (IPE) throughout the cascade of prevention of vertical transmission (PVT) services. MM were implemented in Zambézia Province, Mozambique starting in August 2017. This evaluation aimed to determine the effect of MM on PVT outcomes.MethodsA retrospective interrupted time series analysis was done using routinely collected aggregate data from 85 public health facilities providing HIV services in nine districts of Zambézia. All PPWH (and their IPE) who initiated antiretroviral therapy (ART) from August 2016 through April 2019 were included. Outcomes included the proportion per month per district of: PPWH retained in care 12 months after ART initiation, PPWH with viral suppression and IPE with HIV DNA PCR test positivity by 9 months of age. The effect of MM on outcomes was assessed using logistic regression.ResultsThe odds of 12‐month retention increased 1.5% per month in the pre‐MM period, compared to a monthly increase of 7.6% with‐MM (35–61% pre‐MM, 56–72% with‐MM; p < 0.001). The odds of being virally suppressed decreased by 0.9% per month in the pre‐MM period, compared to a monthly increase of 3.9% with‐MM (49–85% pre‐MM, 59–80% with‐MM; p < 0.001). The odds of DNA PCR positivity by 9 months of age decreased 8.9% per month in the pre‐MM period, compared to a monthly decrease of 0.4% with‐MM (0–14% pre‐MM, 4–10% with‐MM; p < 0.001). The odds of DNA PCR uptake (the proportion of IPE who received DNA PCR testing) by 9 months of age were significantly higher in the with‐MM period compared to the pre‐MM period (48–100% pre‐MM, 87–100% with‐MM; p < 0.001).ConclusionsMM services were associated with improved retention in PVT services and higher viral suppression rates among PPWH. While there was ongoing but diminishing improvement in DNA PCR positivity rates among IPE following MM implementation, this might be explained by increased uptake of HIV testing among high‐risk IPE who were previously not getting tested. Additional efforts are needed to further optimize PVT outcomes, and MM should be one part of a comprehensive strategy to address this critical need.

Factors associated with the risk of HIV infection among HIV-exposed infants in Malawi: 2013–2020

BackgroundDespite the availability of individual-level data of infants accessing HIV DNA-PCR testing service, there has been little in-depth analysis of such data. Therefore, we describe trends in risk of HIV...

Receipt of infant HIV DNA PCR test results is associated with a reduction in retention of HIV-exposed infants in integrated HIV care and healthcare services: a quantitative sub-study nested within a cluster randomised trial in rural Malawi

BackgroundRetention of HIV-infected mothers in integrated HIV and healthcare facilities is effective at reducing mother-to-child-transmission (MTCT) of HIV. In the context of Option B+, we examined maternal and HIV-exposed infant retention across three study arms to 18 months postpartum: mother-and-infant clinics (MIP), MIP with short-messaging service (MIP + SMS) and standard of care (SOC). In particular, we focused on the impact of mothers receiving an infant’s HIV PCR test result on maternal and infant study retention.MethodsA quantitative sub-study nested within a cluster randomised trial undertaken between May 2013 and August 2016 across 30 healthcare facilities in rural Malawi enrolling HIV-infected pregnant mothers and HIV-exposed infants on delivery, was performed. Survival probabilities of maternal and HIV-exposed infant study retention was estimated using Kaplan-Meier curves. Associations between mother’s receiving an infant’s HIV test result and in particular, an infant’s HIV-positive result on maternal and infant study retention were modelled using time-varying multivariate Cox regression.ResultsFour hundred sixty-one, 493, and 396 HIV-infected women and 386, 399, and 300 HIV-exposed infants were enrolled across study arms; MIP, MIP + SMS and SOC, respectively. A total of 47.5% of mothers received their infant’s HIV test results < 5 months postpartum. Receiving an infant’s HIV result by mothers was associated with a 70% increase in infant non-retention in the study compared with not receiving an infant’s result (HR = 1.70; P-value< 0.001). Receiving a HIV-positive result was associated with 3.12 times reduced infant retention compared with a HIV-negative result (P-value< 0.001). Of the infants with a HIV-negative test result, 87% were breastfed at their final study follow-up.ConclusionsReceiving an infant’s HIV test result was a driving factor for reduced infant study retention, especially an infant’s HIV-positive test result. As most HIV-negative infants were still breastfed at their last follow-up, this indicates a large proportion of HIV-exposed infants were potentially at future risk of MTCT of HIV via breastfeeding but were unlikely to undergo follow-up HIV testing after breastfeeding cessation. Future studies to identify and address underlying factors associated with infant HIV testing and reduced infant retention could potentially improve infant retention in HIV/healthcare facilities.Trial registrationPan African Clinical Trial Registry: PACTR201312000678196.

Rate of BCG Immunization in HIV-Exposed Infants in a Selected Primary Health Centre in Southern Nigeria: Implications of No Vaccine Policy for HIV-Positive Infants.

Maternal and infant HIV status influences the decision of BCG immunization of infants at birth. The objective of this study was to determine the HIV status of HIV-exposed infants (HEIs) by the first HIV DNA PCR test and the rate of BCG uptake among the HEIs who were confirmed HIV negative. This was a retrospective descriptive cross-sectional study involving the review of results of 99 dried blood samples (DBS) for the first HIV DNA PCR test of HEIs whose mothers were diagnosed HIV positive on presentation of the infants at first immunization visit at a Primary Health Centre from January 2018 to January 2019. Of the 99 DBS examined, 86; 86.9% (95% CI 80.1-93.6) were HIV negative, 9; 9.1% (95% CI 3.3-14.8) were positive while the results of 4 (4.0%) infants were not in the register. Only 7; 7.1% (95% CI 1.9-12.2) of the 99 HEIs returned for BCG immunization at the centre. BCG immunization status of the HEIs after first PCR results was not significantly associated with sex of the infants or availability of phone number of the guardians (p = 0.70 and 0.12, respectively). The majority of HEIs were HIV negative at first HIV DNA PCR test. Few of these HIV negative infants returned for BCG immunization. Hence, all HEIs should be given BCG immunization according to WHO GAVCS committee recommendation on BCG immunization for settings with poor HIV diagnostic and treatment facilities for mothers and infants.

Missed opportunities for early infant diagnosis of HIV in rural North-Central Nigeria: A cascade analysis from the INSPIRE MoMent study.

BackgroundEarly identification of HIV-infected infants for treatment is critical for survival. Efficient uptake of early infant diagnosis (EID) requires timely presentation of HIV-exposed infants, same-day sample collection, and prompt release of results. The MoMent (Mother Mentor) Nigeria study investigated the impact of structured peer support on EID presentation and maternal retention. This cascade analysis highlights missed opportunities for EID and infant treatment initiation during the study.MethodsHIV-infected pregnant women and their infants were recruited at 20 rural Primary Healthcare Centers. Routine infant HIV DNA PCR testing was performed at centralized laboratories using dried blood spot (DBS) samples ideally collected by age two months. EID outcomes data were abstracted from study case report forms and facility registers. Descriptive statistics summarized gaps and missed opportunities in the EID cascade.ResultsOut of 497 women enrolled, delivery data was available for 445 (90.8%), to whom 415 of 455 (91.2%) infants were live-born. Out of 408 live-born infants with available data, 341 (83.6%) presented for DBS sampling at least once. Only 75.4% (257/341) were sampled, with 81.7% (210/257) sampled at first presentation. Only 199/257 (77.4%) sampled infants had results available up to 28 months post-collection. Two (1.0%) of the 199 infants tested HIV-positive; one infant died before treatment initiation and the other was lost to follow-up.ConclusionsWhile nearly 85% of infants presented for sampling, there were multiple missed opportunities, largely due to health system and not necessarily patient-level failures. These included infants presenting without being sampled, presenting multiple times before samples were collected, and getting sampled but results not forthcoming. Finally, neither of the two HIV-positive infants were linked to treatment within the follow-up period, which may have led to the death of one. To facilitate patient compliance and HIV-free infant survival, quality improvement approaches should be optimized for EID commodity availability, consistent DBS sample collection, efficient processing/result release, and prompt infant treatment initiation.

"Closing the Gap": Provider Recommendations for Implementing Birth Point of Care HIV Testing.

Delays in traditional HIV DNA PCR testing for early infant diagnosis (EID) at 6 weeks of age result in late antiretroviral treatment (ART). Birth point of care (POC) testing is an emerging strategy with the potential to streamline EID services. We elicited providers' recommendations for introducing birth POC testing to guide strategies in Kenya and similar settings. We conducted formative interviews with 26 EID providers from four Kenyan hospitals prior to POC implementation. Providers discussed the need for comprehensive training, covering both EID and POC-specific topics for all key personnel. Providers highlighted equipment considerations, such as protocols for maintenance and safe storage. Providers emphasized the need for maternal counseling to ensure patient acceptance and most agreed that specimen collection for birth POC testing should occur in the maternity department and supported a multidisciplinary approach. Though most providers supported ART initiation based on a positive birth POC result, a few expressed concerns with result validity. To maximize implementation success, provider training, equipment security, maternal counseling, and logistics of testing must be planned and communicated to providers.

Outcome Evaluation of Early Implementation of Option B+ in Cameroon: A Prospective Cohort Observational Survey in the Northwest and Southwest Regions

Background: Mother to child transmission (MTCT) of HIV constitutes a major source of new pediatric infections in Cameroon. Objective: The aim of this implementation research was to assess outcomes and effectiveness of providing life-long antiretroviral therapy (ART) for HIV-positive pregnant and breastfeeding women (Option B+). Methods: From October 2013 to July 2014, HIV-positive pregnant and breastfeeding women, not on antiretroviral (ARV) prophylaxis and ART, were recruited from 22 purposefully selected health facilities in the Northwest and Southwest regions for a prospective, observational cohort evaluation. Option B+ was offered to participants and outcome indicators were measured. Results: Out of 680 women eligible for this assessment, 669 (98%) were initiated on Option B+. Retention-in-care was 90% (95% CI, 87.85 - 92.61) and 79% (95% CI, 75.20 - 81.88), and loss to follow up (LTFU) was 7% (95% CI: 4.95 - 8.90) and 15% (95% CI: 12.06 - 17.56) at 6 and 12 months respectively. Maternal mortality at 12 months after ART initiation was 2% (13). As of March 2015, 538 HIV exposed infants (HEIs) were enrolled and received postpartum nevirapine prophylaxis within 72 hours of birth and 84% (454) were on cotrimoxazole at 6 to 8 weeks. By 8 weeks of age, 498 (93%) infants had HIV DNA PCR test with 486 (97.6%) negative and 12 (2.4%) positive. Conclusion: In Cameroon, successful implementation of Option B+ increased retention-in-care to 79% at one year for pregnant and breastfeeding women and reduced MTCT rate below 5% for HEIs at 8 weeks of age. Long term retention, maternal and infant mortality and final MTCT rate after cessation of breastfeeding require further evaluation.

Optimizing Infant HIV Diagnosis in Resource-Limited Settings: Modeling the Impact of HIV DNA PCR Testing at Birth.

Early antiretroviral therapy (ART) initiation in HIV-infected infants significantly improves survival but is often delayed in resource-limited settings. Adding HIV testing of infants at birth to the current recommendation of testing at age 4-6 weeks may improve testing rates and decrease time to ART initiation. We modeled the benefit of adding HIV testing at birth to the current 6-week testing algorithm. Microsoft Excel was used to create a decision-tree model of the care continuum for the estimated 1,400,000 HIV-infected women and their infants in sub-Saharan Africa in 2012. The model assumed average published rates for facility births (42.9%), prevention of mother-to-child HIV transmission utilization (63%), mother-to-child-transmission rates based on prevention of mother-to-child HIV transmission regimen (5%-40%), return of test results (41%), enrollment in HIV care (52%), and ART initiation (54%). We conducted sensitivity analyses to model the impact of key variables and applied the model to specific country examples. Adding HIV testing at birth would increase the number of infants on ART by 204% by age 18 months. The greatest increase is seen in early ART initiations (543% by age 3 months). The increase would lead to a corresponding increase in survival at 12 months of age, with 5108 fewer infant deaths (44,550, versus 49,658). Adding HIV testing at birth has the potential to improve the number and timing of ART initiation of HIV-infected infants, leading to a decrease in infant mortality. Using this model, countries should investigate a combination of HIV testing at birth and during the early infant period.

Impact of elevated maternal HIV viral load at delivery on T-cell populations in HIV exposed uninfected infants in Mozambique.

BackgroundHIV-uninfected infants born to HIV-infected mothers (HIV-exposed uninfected, HEU) have been described to have immune alterations as compared to unexposed infants. This study sought to characterize T-cell populations after birth in HEU infants and unexposed infants living in a semirural area in southern Mozambique.MethodsBetween August 2008 and June 2009 mother-infant pairs were enrolled at the Manhiça District Hospital at delivery into a prospective observational analysis of immunological and health outcomes in HEU infants. Infants were invited to return at one month of age for a clinical examination, HIV DNA-PCR, and immunophenotypic analyses. The primary analysis sought to assess immunological differences between HEU and unexposed groups, whereas the secondary analysis assessed the impact of maternal HIV RNA viral load in the HEU group. Infants who had a positive HIV DNA-PCR test were not included in the analysis.ResultsAt one month of age, the 74 HEU and the 56 unexposed infants had similar median levels of naïve, memory and activated CD8 and CD4 T-cells. Infant naïve and activated CD8 T-cells were found to be associated with maternal HIV-RNA load at delivery. HEU infants born to women with HIV-RNA loads above 5 log10 copies/mL had lower median levels of naïve CD8 T-cells (p = 0.04), and higher median levels of memory CD8 T-cells, (p = 0.014).ConclusionsThis study suggests that exposure to elevated maternal HIV-RNA puts the infant at higher risk of having early T-cell abnormalities. Improving prophylaxis of mother to child HIV programs such that more women have undetectable viral load is crucial to decrease vertical transmission of HIV, but may also be important to reduce the consequences of HIV virus exposure in HEU infants.

Massage therapy improves the development of HIV-exposed infants living in a low socio-economic, peri-urban community of South Africa

The aim of this study was to assess the effect of massage therapy on the growth and development of infants of HIV-infected mothers in a low socio-economic community in Cape Town. It was a prospective, randomised, controlled intervention trial that included massage therapy and control groups of HIV-infected mothers and their normal birth weight infants who were enrolled in the prevention of mother-to-child transmission (PMTCT) programme. Participants were recruited at the 6-week clinic visit and followed up every 2 weeks until their infants were 9 months of age. Mother–infant pairs in the massage therapy and control groups included 73 and 88 at 6 weeks and 55 and 58 at 9 months, respectively. Mothers in the intervention group were trained to massage their infants for 15min daily. The socioeconomic status, immunity, relationship with the partner and mental pain of mothers; the infants’ dietary intake, anthropometry and development (Griffiths Mental Development Scales); and haematological and iron status of mothers and infants were assessed at baseline and follow-up. Nine infants (5.3%) were HIV-infected on the HIV DNA PCR test at 6 weeks. Despite significantly higher levels of maternal mental pain, infants in the massage therapy compared to control group scored higher in all five of the Griffiths Scales of Mental Development and significantly higher in the mean quotient (p=0.002) and mean percentile (p=0.004) for the hearing and speech scale at 9 months. Based on the mean difference in scores, the massage therapy group showed greater improvement for all five scales compared to the control group. The mean difference in scores was significantly greater for the hearing and speech quotient (21.9 vs. 11.2) (p<0.03) and the general quotient percentile (19.3 vs. 7.7) (p=0.03) in the massage therapy compared to the control group. These scales remained significant when adjusting for the relationship with the partner and maternal mental pain. Both groups had lower scores in the performance scale at 9 months although this was significantly worse in the control compared to the massage therapy group when adjusting for maternal CD4 count, anaemia, relationship with the partner and mental pain. There were no significant differences in the anthropometric measurements between the two groups. In conclusion, based on the Griffiths Scales, massage therapy improved the overall development and had a significant effect on the hearing and speech and general quotient of HIV-exposed infants in this study.

Outcomes of Infants Born to HIV-Infected Women Identified by Rapid HIV Testing Late in Pregnancy or at Delivery: The MIRIAD Study

Background: Rapid HIV testing late in pregnancy or at delivery provides a final opportunity (among non-breastfeeding mothers) to identify HIV-infected women and initiate antiretroviral drugs to prevent mother-to-child transmission. Methods: MIRIAD was a CDC-funded study conducted from 2001-2005 at 17 hospitals in 6 US cities. Eligible women had undocumented HIV status when presenting in labor or after 34 weeks gestation and not in labor. We performed both rapid HIV-1 antibody testing of blood and conventional enzyme immunoassay with Western blot confirmation. Women and infants were managed according to the local standard of care. Infant infection status was determined by HIV DNA or RNA PCR testing. Results: Fifty-one infants (1 pair of twins) were born to 50 women. Among those with data available, 17% of women received prenatal antiretroviral and 71% received intrapartum antiretroviral, including 64% of those identified during labor. All 49 infants with available data received antiretroviral. Forty-four infants had adequate samples to determine their infection status and 5 were infected (11.4%, 95% CI: 1.9 - 20.7%); 3 had in utero, 1 intrapartum, and 1 indeterminate timing of transmission. No infant whose mother received prenatal antiretroviral was infected. The estimated rate of intrapartum transmission among infants with defined infection status was 4.5%. Conclusions: Rapid HIV testing late in pregnancy or even during labor, allowing the administration of antiretroviral to infected women, reduces intrapartum HIV transmission. This highlights the importance of offering rapid HIV testing to pregnant women, with unknown HIV status late in pregnancy.

Pharmacokinetics, safety and transplacental passage of rilpivirine in pregnancy

Pharmacokinetics, safety and transplacental passage of rilpivirine in pregnancy

Delay in Early Infant Diagnosis and High Loss to Follow-Up among Infant Born to HIV-Infected Women in Ethiopia

Background: Many HIV-infected infants and children die from HIV related causes without their HIV status being known or receiving HIV care. All HIV exposed infants should be tested by Dried Blood Spots (DBS)-PCR before or at 6 weeks of age. Testing is a crucial step to facilitate early access to antiretroviral treatment (ART). However, studies that assess the level of use and implementation of HIV DNA testing in Ethiopia are lacking. Objective: To investigate the rate of early infant diagnosis (EID), defined as having blood drawn for HIV DNA-PCR testing, and predictive factors of EID among infants born to HIV infected women. Method: A multicentre retrospective cohort study was conducted from April to June 2012 in three public hospitals and three health centers, in Northwest Ethiopia. Mother-infant pairs were followed from delivery until the time of the HIV diagnostic test. Data were captured using standardized forms. The time-to-diagnostic test was estimated using Kaplan-Meier estimators. Factors associated with EID were evaluated using logistic regression. Result: Of the 266 HIV-exposed infants identified from the health facilities, only 109 (41.0%) infants had early HIV DNA-PCR tests. The median age at the time of HIV diagnostic testing was 60 days (95% CI: 47 - 73 days), and the median turnaround time between blood draw for DNA-PCR testing to delivery of a test result to the respective health facility was 36 days (95% CI: 33 - 40 days). A total of 35 (13.2%) infants were diagnosed with HIV infection. The predictors of EID were the mother having prenatal care, maternal receipt of ART during pregnancy and place of birth. Conclusion: Three out of five HIV-infected women did not bring their infant for HIV testing during the recommended 6 week interval after birth. Special attention is required for infants born to HIV-infected women who did not receive ART or delivered at home or a private health facility to ensure early infant diagnosis, reduce loss to follow-up and prevent late initiation of ART for HIV-infected infants.

False-positive HIV DNA PCR testing of infants

False-positive HIV DNA PCR testing of infants

Development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China

This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present, the HIV/AIDS testing laboratories includes three classes, the National AIDS Reference Laboratory, HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities, and each class of laboratories take charge of their function strictly according to the “National Management of HIV/AIDS Detection (2006)”. A complete quality assurance and quality control system for HIV/AIDS testing has been developed, which includes technical training, strict laboratory monitoring and approval, examination or proficiency testing on HIV/AIDS detection, and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test, more and more laboratories began to conduct other tests, such as CD4+T lymphocyte cell counting, HIV viral load, HIV DNA PCR, genotyping, drug resistance, and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example, the provincial PT program is inefficient, the internal quality control is conducted perfunctorily, personnel training can not met the needs of the workplace, which need to be improved.