The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes—A randomized clinical trial

Atuhaire, Patience; Brummel, Sean; Mmbaga, Blandina T.; Angelidou, Konstantia; Fairlie, Lee; Violari, Avy; Theron, Gerhard; Mukuzunga, Cornelius; Mawlana, Sajeeda; Mubiana‐Mbewe, Mwangelwa; Naidoo, Mergan; Makanani, Bonus; Mandima, Patricia; Nematadzira, Teacler; Suryavanshi, Nishi; Mbengeranwa, Tapiwa; Loftis, Amy James; Basar, Michael; McCarthy, Katie; Currier, Judith S.; Fowler, Mary Glenn; Team, FF Promise Study

doi:10.1371/journal.pone.0228003

Cited by 3 publications

(2 citation statements)

References 10 publications

(19 reference statements)

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“…A similar study by Atuhaire et al . [ 44 ] in 2015 among PWLHIV at five local authority health facilities also noted a difference in practices in VL testing among the facilities, however it was noted that more research was required to establish the cause of such differences. Lessons learned from the Therapeutic Solidarity and Initiatives against AIDS, OPP-ERA project in five West African countries showed that disparities in VL sample collection can be due to multiple determinants including the number, training and availability of health staff, size of the HIV cohort at the facility, and organisation of the sample collection circuit [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Viral load testing among pregnant women living with HIV in Mutare district of Manicaland province, Zimbabwe

et al. 2022

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Background Viral load (VL) monitoring of pregnant women living with HIV (PWLHIV) and antiretroviral therapy (ART) may contribute to lowering the risk of vertical transmission of HIV. The aims of this study were to assess the uptake of HIV VL testing among PWLHIV at entry to the prevention-of-mother-to-child transmission (PMTCT) services and identify facilitatory factors and barriers to HIV VL access. Methods A retrospective, cross-sectional study was conducted at 15 health facilities in Mutare district, Manicaland Province, Zimbabwe from January to December 2018. This analysis was complemented by prospective interviews with PWLHIV and health care providers between October 2019 and March 2020. Quantitative data were analysed using descriptive and inferential statistical methods. Risk factors were evaluated using multivariate logistic regression. Open-ended questions were analysed and recurring and shared experiences and perceptions of PWLHIV and health care providers identified. Results Among 383 PWLHIV, enrolled in antenatal care (ANC) and receiving ART, only 121 (31.6%) had a VL sample collected and 106 (88%) received their results. Among these 106 women, 93 (87.7%) had a VL < 1000 copies/mL and 77 (73%) a VL < 50 copies/mL. The overall median duration from ANC booking to VL sample collection was 87 (IQR, 7–215) days. The median time interval for the return of VL results from date of sample collection was 14 days (IQR, 7–30). There was no significant difference when this variable was stratified by time of ART initiation. VL samples were significantly less likely to be collected at local authority compared to government facilities (aOR = 0.28; 95% CI 0.16–0.48). Barriers to VL testing included staff shortages, non-availability of consumables and sub-optimal sample transportation. Turnaround time was prolonged by the manual results feedback system. Conclusions and recommendation The low rate of HIV VL testing among PWLHIV in Mutare district is a cause for concern. To reverse this situation, the Ministry of Health should consider interventions such as disseminating antiretroviral guidelines and policies electronically, conducting regular PMTCT mentorship for clinical staff members, and utilising point of care testing and telecommunication devices like mHealth to increase uptake of VL testing and improve results turnaround time.

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Section: Discussionmentioning

confidence: 99%

Viral load testing among pregnant women living with HIV in Mutare district of Manicaland province, Zimbabwe

et al. 2022

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“…The characteristics assessed for association with viral suppression used in this study were based on the baseline data collected in the PROMOTE study. Of these, the ones selected for the adjusted odds ratio based on those characteristics found to be significantly associated with viral suppression in literature are as follows: age [ 1 , 3 , 34 ], duration on treatment [ 2 , 27 ], and disclosure to partner or partner support [ 1 , 2 , 7 , 35 ]. Randomization, pill count eligibility, as well as treatment switch were additional characteristics explored in this study as they were required to address the study objectives.…”

Section: Discussionmentioning

confidence: 99%

Impact of Motivational Enhanced Adherence Counseling and Point-of-Care Viral Load Monitoring on Viral Load Outcome in Women on Life-Long ART: A Randomized Pilot Study

Mutambanengwe-Jacob

Maponga

Amico

et al. 2022

AIDS Research and Treatment

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We piloted the combined effectiveness of point-of-care viral load monitoring plus motivational enhanced adherence counseling (intervention) compared with routine care (control) in women identified at risk of virologic failure in the PROMOTE study in Zimbabwe. In an unblinded randomized study, consenting women with last viral load ≥200 copies/ml and/or pill count outside 90–110% range were randomized 1 : 1 to receive the intervention or continue routine care, comprising laboratory-based VL monitoring and standard EAC, from trained nurses and counsellors. Viral load was measured 0, 3, 6, and 12 months after enrolment. We compared viral suppression <200 copies/ml at 6 and 12 months between the arms through Fisher’s exact test and sought associated factors by logistic regression with a 95% confidence interval (CI). Between December 2018 and July 2019, 50 women were enrolled (25 intervention and 25 controls) and followed until November 2020. At entry, 60% of the women were virally suppressed, 52% intervention vs. 68% control arm. Viral suppression was balanced between the two arms ( p value = 0.248). At month 6 post study entry (primary endpont), 64% of the women retained in care were virally suppressed, 54% intervention vs. 76% control arm ( p value = 0.124). At month12 post study entry (secondary endpoint), 69% of the women retained in care were virally suppressed, 67% intervention vs. 71% control arm women ( p value = 0.739). More intervention women completed all scheduled sessions by month 6. Control group women were more likely to be virally suppressed at both timepoints. Only 25% had treatment switch by 12 months. Despite intense adherence support and viral load monitoring, sustained viral suppression remained elusive in women identified at risk of viral failure. These findings highlight the continued need for effective adherence intervention for women with unsuppressed HIV viral loads, efficient treatment switch strategies, as well as drug level monitoring.

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Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding

Brummel

Taha

Angelidou

et al. 2021

JAIDS Journal of Acquired Immune Deficiency Syndromes

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IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART: N = 289) or discontinue ART (N = 268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS-defining illnesses were reported during follow-up in either arm. Adverse events of grade 3 or higher were more frequent in the CTART arm [hazard ratio = 1.78, 95% confidence interval: (1.05 to 3.02), P-value = 0.03]. The difference in adverse events in the 2 groups was mostly driven by moderate weight loss for women on the CTART arm.

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The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes—A randomized clinical trial

Cited by 3 publications

References 10 publications

Viral load testing among pregnant women living with HIV in Mutare district of Manicaland province, Zimbabwe

Viral load testing among pregnant women living with HIV in Mutare district of Manicaland province, Zimbabwe

Impact of Motivational Enhanced Adherence Counseling and Point-of-Care Viral Load Monitoring on Viral Load Outcome in Women on Life-Long ART: A Randomized Pilot Study

Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding

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