Joanna Orne-Gliemann

Implementing a rural programme of prevention of mother-to-child transmission of HIV in Zimbabwe: first 18 months of experience.

Objective  To report on activities and lessons learned during the first 18 months of a rural programme of prevention of mother‐to‐child transmission of HIV (PMTCT) in Zimbabwe.

Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial

BackgroundAntiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial’s secondary outcomes.Methods/designA cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters.DiscussionWe aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability.Trial registrationClinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.

Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study.

BackgroundA large proportion of the 2.5 million new adult HIV infections that occurred worldwide in 2007 were in stable couples. Feasible and acceptable strategies to improve HIV prevention in a conjugal context are scarce. In the preparatory phase of the ANRS 12127 Prenahtest multi-site HIV prevention trial, we assessed the acceptability of couple-oriented post-test HIV counseling (COC) and mens involvement within prenatal care services, among pregnant women, male partners and health care workers in Cameroon, Dominican Republic, Georgia and India.MethodsQuantitative and qualitative research methods were used: direct observations of health services; in-depth interviews with women, men and health care workers; monitoring of the COC intervention and exit interviews with COC participants.ResultsIn-depth interviews conducted with 92 key informants across the four sites indicated that men rarely participated in antenatal care (ANC) services, mainly because these are traditionally and programmatically a womans domain. However mens involvement was reported to be acceptable and needed in order to improve ANC and HIV prevention services. COC was considered by the respondents to be a feasible and acceptable strategy to actively encourage men to participate in prenatal HIV counseling and testing and overall in reproductive health services.ConclusionsOne of the keys to mens involvement within prenatal HIV counseling and testing is the better understanding of couple relationships, attitudes and communication patterns between men and women, in terms of HIV and sexual and reproductive health; this conjugal context should be taken into account in the provision of quality prenatal HIV counseling, which aims at integrated PMTCT and primary prevention of HIV.

Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa : Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial

Background The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART. Methods and Findings Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count ≤ 350 cells/μl at first visit, of whom 92.8% initiated ART within 3 mo. Regarding attitudes about ART, 93% (8,802/9,460) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive. Estimated baseline HIV prevalence was 30.5% (2,028/6,656) (95% CI 25.0%, 37.0%). HIV prevalence, uptake of home-based HIV testing, linkage to care within 6 mo, and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters. Selection bias related to noncontact could not be entirely excluded. Conclusions Home-based HIV testing was well received in this rural population, although men were less easily contactable at home; immediate ART was acceptable, with good viral suppression and retention. However, only about half of HIV-positive people accessed care within 6 mo of being identified, with nearly two-thirds accessing care by 12 mo. The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population. Trial registration ClinicalTrials.gov NCT01509508

Increasing HIV testing among male partners

Objective:Couple-oriented posttest HIV counselling (COC) provides pregnant women with tools and strategies to invite her partner to HIV counselling and testing. We conducted a randomized trial of the efficacy of COC on partner HIV testing in low/medium HIV prevalence settings (Cameroon, Dominican Republic, Georgia, India). Methods:Pregnant women were randomized to receive standard posttest HIV counselling or COC and followed until 6 months postpartum. Partner HIV testing events were notified by site laboratories, self-reported by women or both combined. Impact of COC on partner HIV testing was measured in intention-to-treat analysis. Socio-behavioural factors associated with partner HIV testing were evaluated using multivariable logistic regression. Results:Among 1943 pregnant women enrolled, partner HIV testing rates (combined indicator) were 24.7% among women from COC group versus 14.3% in standard posttest HIV counselling group in Cameroon [odds ratio (OR) = 2.0 95% CI (1.2–3.1)], 23.1 versus 20.3% in Dominican Republic [OR = 1.2 (0.8–1.8)], 26.8 versus 1.2% in Georgia [OR = 29.6 (9.1–95.6)] and 35.4 versus 26.6% in India [OR = 1.5 (1.0–2.2)]. Women having received COC did not report more conjugal violence or union break-ups than in the standard posttest HIV counselling group. The main factors associated with partner HIV testing were a history of HIV testing among men in Cameroon, Dominican Republic and Georgia and the existence of couple communication around HIV testing in Georgia and India. Conclusion:A simple prenatal intervention taking into account the couple relationship increases the uptake of HIV testing among men in different socio-cultural settings. COC could contribute to the efforts towards eliminating mother-to-child transmission of HIV.

Defining and analyzing retention-in-care among pregnant and breastfeeding HIV-infected women: unpacking the data to interpret and improve PMTCT outcomes.

Abstract:The prevent mother-to-child transmission (PMTCT) “cascade” describes the programmatic steps for pregnant and breastfeeding women that influence HIV transmission rates. To this end, HIV-infected pregnant women and mothers need access to health services and adhere to antiretroviral (ARV) prophylaxis or lifetime treatment. Within the cascade, the concept of “retention-in-care” is commonly used as a proxy for adherence to ARV interventions and, even, viral suppression. Yet surprisingly, there is no standard definition of retention-in-care either for the purposes of HIV surveillance or implementation research. Implicit to the concept of retention-in-care is the sense of continuity and receipt of care at relevant time points. In the context of PMTCT, the main challenge for surveillance and implementation research is to estimate effective coverage of ARV interventions over a prolonged period of time. These data are used to inform program management and also to estimate postnatal MTCT rates. Attendance of HIV-infected mothers at clinic at 12-month postpartum is often equated with full retention in PMTCT programs over this period. Yet, measurement approaches that fail to register missed visits, or inconsistent attendance or other missing data in the interval period, fail to capture patterns of attendance and care received by mothers and children and risk introducing systematic errors and bias. More importantly, providing only an aggregated rate of attendance as a proxy for retention-in-care fails to identify specific gaps in health services where interventions to improve retention along the PMTCT cascade are most needed. In this article, we discuss how data on retention-in-care can be understood and analyzed, and what are the implications and opportunities for programs and implementation research.

Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal

BackgroundThe Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies.Methods/designA social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods.DiscussionThe UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at individual, community, patient and health system level, to complement the trial’s clinical and epidemiological outcomes. It will also increase understanding of the causal impacts of UTT on social and economic outcomes, which will be critical for the long-term sustainability and routine UTT implementation.Trial registrationClinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.

Continuum in HIV care from entry to ART initiation in rural KwaZulu-Natal, South Africa.

To quantify time from entry in HIV care until Antiretroviral therapy (ART) initiation and identify factors associated with ART initiation in rural KwaZulu‐Natal, South Africa.

Access to HIV care in the context of universal test and treat : challenges within the ANRS 12249 TasP cluster-randomized trial in rural South Africa

We aimed to quantify and identify associated factors of linkage to HIV care following home‐based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment‐as‐prevention (TasP) cluster‐randomized trial in rural KwaZulu‐Natal, South Africa.

Effectiveness of Multidrug Antiretroviral Regimens to Prevent Mother-to-Child Transmission of HIV-1 in Routine Public Health Services in Cameroon

Background Multidrug antiretroviral (ARV) regimens including HAART and short-course dual antiretroviral (sc-dARV) regimens were introduced in 2004 to improve Prevention of Mother-to-Child Transmission (PMTCT) in Cameroon. We assessed the effectiveness of these regimens from 6–10 weeks and 12 months of age, respectively. Methodology/Findings We conducted a retrospective cohort study covering the period from October 2004 to March 2008 in a reference hospital in Cameroon. HIV-positive pregnant women with CD4 ≤350 cells/mm3 received first-line HAART [regimen 1] while the others received ARV prophylaxis including sc-dARV or single dose nevirapine (sd-NVP). Sc-dARV included at least two drugs according to different gestational ages: zidovudine (ZDV) from 28–32 weeks plus sd-NVP [regimen 2], ZDV and lamuvidine (3TC) from 33–36 weeks plus sd-NVP [regimen 3]. When gestational age was ≥37 weeks, women received sd-NVP during labour [regimen 4]. Infants received sd-NVP plus ZDV and 3TC for 7 days or 30 days. Early diagnosis (6–10 weeks) was done, using b-DNA and subsequently RT-PCR. We determined early MTCT rate and associated risk factors using logistic regression. The 12-month HIV-free survival was assessed using Cox regression. Among 418 mothers, 335 (80%) received multidrug ARV regimens (1, 2, and 3) and MTCT rate with multidrug regimens was 6.6% [95%CI: 4.3–9.6] at 6 weeks, without any significant difference between regimens. Duration of mothers ARV regimen <4 weeks [OR = 4.7, 95%CI: 1.3–17.6], mothers CD4 <350 cells/mm3 [OR = 6.4, 95%CI: 1.8–22.5] and low birth weight [OR = 4.0, 95%CI: 1.4–11.3] were associated with early MTCT. By 12 months, mixed feeding [HR = 8.7, 95%CI: 3.6–20.6], prematurity [HR = 2.3, 95%CI: 1.2–4.3] and low birth weight were associated with childrens risk of progressing to infection or death. Conclusions Multidrug ARV regimens for PMTCT are feasible and effective in routine reference hospital. Early initiation of ARV during pregnancy and proper obstetrical care are essential to improve PMTCT.