Gita Ramjee

• PhD
• Managing Director at South African Medical Research Council

Over the past two decades, numerous HIV prevention trials have targeted thousands of young African women, aiming not only to reduce transmissions through biomedical interventions but also to promote safe sexual practices through intensive risk reduction sessions. The primary objective of this study was to review the impact of risk reduction session...

South Africa is faced with a high HIV and STI prevalence and incidence, respectively, with pockets of high burden areas driving these diseases. Localised monitoring of the HIV epidemic and STI endemic would enable more effective targeted prevention strategies. We assessed spatial variations in curable STI incidence among a cohort of women enrolled...

OBJECTIVE: Development of immunogens that elicit an anti-HIV-1 broadly neutralizing antibody (bnAb) response will be a key step in the development of an effective HIV-1 vaccine. Although HIV-1 bnAb epitopes have been identified and mechanisms of action studied, current HIV-1 envelope-based immunogens do not elicit HIV-1 bnAbs in humans or animal mo...

Curable sexually transmitted infections (STIs) affect millions of people across the world. Besides unacceptably high HIV rates, South Africa also has the highest burden of STIs in the world. The aim of the study was to investigate temporal changes in STI incidence rates using the data from ~ 10,000 women who enrolled in several HIV prevention trial...

Introduction: Whether intramuscular depot medroxyprogesterone acetate (DMPA-IM) and norethisterone enanthate (NET-EN) have a differential impact on the incidence of sexually transmitted infection (STI) remains unclear. In the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial, HIV-1 acquisition was higher for DMPA-IM users vs. NET...

Objective: Development of immunogens that elicit an anti-HIV-1 broadly neutralizing antibody (bnAb) response will be a key step in the development of an effective HIV-1 vaccine. Although HIV-1 bnAb epitopes have been identified and mechanisms of action studied, current HIV-1 Envelope based immunogens do not elicit HIV-1 bnAbs in humans or animal m...

In this study, we investigated spatial diversities of sexually transmitted infections (STIs) and quantified their impacts on the STIs using population attributable risk (PAR%). The study population was 7,557 women who participated in several HIV prevention trials from KwaZulu-Natal, South Africa. Our results provide compelling evidence for substant...

Despite expanded antiretroviral therapy (ART) eligibility in South Africa, many people diagnosed with HIV do not initiate ART promptly, yet understanding of the reasons is limited. Using data from an 8-month prospective cohort interview study of women and men newly-diagnosed with HIV in three public-sector primary care clinics in the eThekwini (Dur...

Despite expanded antiretroviral therapy (ART) eligibility in South Africa, many people diagnosed with HIV do not initiate ART promptly, yet understanding of the reasons is limited. Using data from an 8-month prospective cohort interview study of women and men newly-diagnosed with HIV in three public-sector primary care clinics in the eThekwini (Dur...

Background Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection...

Low adherence in vaginal microbicide clinical trials for HIV prevention has impeded interpretation of trial results and hindered evaluation of potentially efficacious HIV prevention gels. Understanding the underlying reasons why women join trials and their barriers to product use can support identification of ways to improve adherence and its repor...

In addition to being the epicentre of the HIV epidemic, South Africa also has the highest burden of sexually transmitted infections (STIs) in the world. Therefore, understanding the most influential risk factors of STIs is a research priority. Using the data from 9948 women who resided in KwaZulu Natal, South Africa, we estimated the population att...

South Africa has the highest burden of human immunodeficiency virus (HIV) infections in the world. There is also growing evidence that an individual’s risk of contracting HIV is increased by the presence of other sexually transmitted infections (STIs). The primary objective of this study was to examine the association between the prevalence of STIs...

Medical male circumcision is a proven method of HIV risk reduction in men with no known direct benefit to women. We investigated the benefit of partner circumcision on women's health. We conducted a secondary analysis of 5,029 women enrolled in the Vaginal and Oral Interventions to Control the Epidemic trial across 15 African sites, to look at the...

South Africa has the highest number of HIV infected individuals in the world. The primary objective of the current study was to describe temporal changes in HIV incidence rates using the data from 9,948 women who enrolled in one of the six HIV prevention trials conducted in KwaZulu-Natal, South Africa. Characteristics of the study population were p...

Objective Despite all efforts, high pregnancy rates are often reported in HIV biomedical intervention trials conducted in African countries. We therefore aimed to develop a pregnancy risk scoring algorithm for targeted recruitment and screening strategies among a cohort of women in South Africa. Methods The study population was ∼10,000 women who e...

Linkage to care following an HIV diagnosis remains an important HIV care continuum milestone, even in the era of universal ART eligibility. In an 8-month prospective cohort study among 459 (309 women, 150 men) newly-diagnosed HIV-positive individuals in three public-sector clinics in Durban metropolitan region, South Africa, from 2010 to 2013, medi...

Background: The high burden of disease in South Africa presents challenges to public health services. Point-of-care (POC) technologies have the potential to address these gaps and improve healthcare systems. This study ascertained the acceptability and impact of POC CD4 testing on patients’ health and clinical management. Methods: We conducted a qu...

Background: The Pox-Protein Public-Private Partnership (P5) is performing a suite of trials to evaluate the bivalent subtype C envelope (Env) protein (TV1.C and 1086.C gp120) vaccine in the context of different adjuvants and priming agents for HIV-1 prevention. Methods: In the HIV Vaccine Trials Network (HVTN) 111 trial, we compared safety and i...

Background: WHO guidelines recommend co-trimoxazole prophylaxis for HIV-exposed, HIV-uninfected infants. These guidelines date back to an era in which HIV testing of infants was impossible and mothers had poor access to antiretroviral treatment. To determine whether this guideline requires revision in the current era of effective prevention of mot...

Objective: The aim of this proof of concept study was to determine the effect of depot medroxyprogesterone acetate on host and viral factors in HIV infected and uninfected women. Results: In this study, the gene expression levels for CCL5, CCR5 and CXCR4 was significantly higher in HIV positive women when compared to HIV negative women (p < 0.05...

Background: With the largest antiretroviral therapy (ART) programme globally, demand for effective HIV management is increasing in South Africa. While viral load (VL) testing is conducted, VL follow-up and management are sub-optimal. Objectives: The objective of this study was to address gaps in the VL cascade to improve VL testing and management....

Background: With Universal Health Coverage and Integrated People-centred Health Care, streamlined health-systems and respectful care are necessary. South Africa has made great strides in prevention of mother-to-child transmission (PMTCT) but with the great burden of HIV, a minimum of birth and 10-week HIV-PCR testing are required for the estimated...

Abstract Background Fine scale geospatial analysis of HIV infection patterns can be used to facilitate geographically targeted interventions. Our objective was to use the geospatial technology to map age and time standardized HIV incidence rates over a period of 10 years to identify communities at high risk of HIV in the greater Durban area. Method...

Background A high endogenous progesterone luteal state in the menstrual cycle has been independently associated with Human Immunodeficiency Virus (HIV) incidence in epidemiological studies. Hormonal contraception particularly high dose Depot Medroxyprogesterone Acetate (DMPA) is also thought to increase the risk of HIV acquisition. Inconsistent rep...

Objective: We identified the geographical clustering of HIV as well as those at highest risk of infection using a decade long data (2002-2012) from KwaZulu-Natal, South Africa. Methods: A total of 5,776 women who enrolled in several HIV prevention trials were included in the study. Geo-coded individual-level data were linked to the community-lev...

Background There remains an urgent need for a prophylactic HIV vaccine to control generalised epidemics. PrEP has demonstrated effectiveness of 86% and is recommended by WHO; uptake is generally high, but retention is disappointing in some settings. The EDCTP2 project PrEPVacc will assess the efficacy of two combination prophylactic vaccine regimen...

Background: South Africa has the largest public antiretroviral therapy (ART) programme in the world. We assessed temporal trends in pretreatment HIV-1 drug resistance (PDR) in ART-naïve adults from South Africa. Methods: We included datasets from studies conducted between 2000 and 2016, with HIV-1 pol sequences from more than ten ART-naïve adult...

South Africa has the highest burden of human immunodeficiency virus (HIV) infections in the world with significant geographical variations. We identified the predictors of HIV infections and their sub-geographical-level contributions to the epidemic using a decade long data (2002–2012) from 6484 South African women. Generalized additive models were...

The biosocial background in which the hepatitis B virus (HBV) carrier state with membranous nephropathy (MN) develops was studied by evaluating HBV carriage and proteinuria among 195 family members and household contacts of 31 index HBV carrier children with MN. Unrelated individuals from the communities of these index cases who were negative for H...

Background: A vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and response to NNRTI-containing antiretrovir...

Despite the salience of social support and violence as potential outcomes of disclosure, how pre-existing social support and relationship violence among people living with HIV shapes and influences HIV status disclosure has received limited attention. Following the Disclosure Process Model, this study investigated pre-disclosure support and violenc...

Introduction: There are few data on the frequency of virological remission in African individuals after treatment with antiretroviral therapy (ART) in primary HIV infection (PHI). Methods: We studied participants (n = 82) from South Africa and Uganda in SPARTAC, the first trial of treatment interruption (TI) in African individuals with PHI randomi...

Introduction: As we approach the fourth decade with human immunodeficiency virus (HIV), a plethora of prevention interventions have been tried; however, prevention of new infections among women remain poorly understood and current behavioral change interventions are simply not working. Material and methods: We investigate whether women's sexual beh...

Studies have shown that women diagnosed with herpes simplex virus-2 (HSV-2) have a higher risk for bacterial vaginosis (BV) infection. We investigated the presence of HSV-2 infections as a risk factor for incident BV infections in high risk, Human immunodeficiency virus (HIV) uninfected women enrolled in a HIV prevention trial in Durban, South Afri...

Background: Women enrolled in HIV prevention efficacy trials, are counselled at every visit on prevention of HIV, STIs and pregnancy. Incident pregnancy impacts on efficacy outcomes. Incidence rates of pregnancy and HIV/STIs among women who became pregnant and associated risk factors were assessed. Methods: Data from 9165 women participating in...

Background Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives This Phase I, randomized, crossover trial assessed an...

Summary of adverse event occurrence rates by center. (PDF)

Data points for sexually transmitted infections and bacterial vaginosis. (PDF)

Summary of adverse event occurrence rates by trial phase. (PDF)

Data points for baseline demographics. (PDF)

Summary of adverse event occurrence rates by sequence assignment. (PDF)

Efforts to both characterize and eradicate the HIV reservoir have been limited by the rarity of latently infected cells and the absence of a specific denoting biomarker. CD32a (FcγRIIa) has been proposed to be a marker for an enriched CD4 T cell HIV reservoir, but this finding remains controversial. Here, we explore the expression of CD32 on CD3⁺CD...

This study aims to examine sexual activity and healthcare-seeking behaviour in HIV-infected and uninfected adults aged 50 years and older. The data utilised is from a cross-sectional study conducted among older adults in semi-rural and urban communities of Durban, KwaZulu-Natal, South Africa. Descriptive statistics are used to describe the study sa...

We aimed to develop a HIV risk scoring algorithm for targeted screening among women in South Africa. We used data from five biomedical intervention trials (N = 8982 Cox regression models were used to create a risk prediction algorithm and it was internally and externally validated using standard statistical measures; 7-factors were identified as si...

Background: The Afinion AS100 analyser is a small bench-top, multi-assay, point-of-care (POC) analyser that is able to measure glycated haemoglobin (HbA1c) and lipid levels. Objective: To assess performance of the Afinion analyser compared with a reference laboratory test for the measurement of HbA1c and lipid levels. Method: The study involve...

Background. The Afinion AS100 analyser is a small bench-top, multi-assay, point-of-care (POC) analyser that is able to measure glycated haemoglobin (HbA1c) and lipid levels.Objective. To assess performance of the Afinion analyser compared with a reference laboratory test for the measurement of HbA1c and lipid levels.Method. The study involved men a...

Setting: In South Africa, KwaZulu-Natal is the epicentre of the human immunodeficiency virus (HIV) epidemic, where approximately 70% of people with tuberculosis (TB) are co-infected with HIV. Undiagnosed TB contributes to high mortality in HIV-infected patients. Delays in diagnosing TB and treatment initiation result in prolonged transmission and...

The Fc receptor CD32 has been proposed as a marker for CD4 T cells latently infected with HIV. We demonstrate that enrichment for HIV DNA in CD32+ CD4 T cells can be found early in infection in both tissue and blood. However, we find no evidence for a correlation between CD32 expression on CD4 T cells and either HIV DNA levels or time to rebound vi...

Few studies have examined HIV-testing decision-making since the South African national HIV counseling and testing campaign in 2010–2011 and subsequent expansion in antiretroviral therapy (ART) eligibility in 2012. We describe HIV-testing decision-making and pathways to testing among participants in Pathways to Care, a cohort study of newly-diagnose...

Background Little is known regarding HIV disease outcomes among individuals who become infected with HIV while receiving antiretroviral medications for prevention. We compared HIV disease parameters among women who seroconverted while receiving tenofovir-containing oral or vaginal pre-exposure prophylaxis (PrEP) to placebo. Methods Participants wi...

Sub-Saharan Africa has the highest number of HIV infected individuals in the world. Developing and implementing effective biomedical interventions still remains urgent. Poor adherence has been commonly identified as one of the major barriers for the success of HIV prevention trials. A better understanding of how to improve adherence remains a resea...

Background Herpes Simplex Virus 2 (HSV-2) is one of the most common sexually transmitted infections (STIs) worldwide and is a risk factor for the acquisition and transmission of other STIs, including HIV. We determined the prevalence and predictors of HSV-2 infection among women screened for a HIV prevention trial in Durban, South Africa. Univariat...

Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Mon...

Background Timely linkage to care by newly-diagnosed HIV+ individuals remains a significant challenge to achieving UNAIDS 90-90-90 goals. Current World Health Organization (WHO) guidelines recommend initiating anti-retroviral treatment (ART) regardless of CD4+ count, with priority given to those with CD4+ <350 cells/μl. We evaluated the impact of n...

Underlying Data. (XLSX)

Description of the population at screening, overall and by enrollment status, Durban, South Africa, 2010–2012. (DOCX)

Total CD4 T-cell counts predict HIV disease progression but do not necessarily reflect normalization of immune function. CD4/CD8 ratio is a marker of immune dysfunction, a prognostic indicator for non-AIDS mortality, and reflects viral reservoir size. Despite antiretroviral therapy (ART), recovery of CD4/CD8 ratio in chronic HIV infection is incomp...

Introduction No randomised controlled trial (RCT) has examined the efficacy of cotrimoxazole (CTX) prophylaxis in HIV-exposed uninfected (HEU) infants during the breastfeeding period, in this new era of effective prevention of mother-to-child transmission (PMTCT) prophylaxis. The efficacy of CTX prophylaxis has presently been demonstrated only in H...

This article describes the influence of a peer education programme on skills development among 22 women participating in HIV prevention trials. Interviews were used to collect data on peer educator experiences and their opinions of the trainings. The training enhanced their agency and confidence to engage their family and community on health promot...

Introduction Limited information is available on the usefulness of the PIMA™ analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa. Materials and methods The study was conducted under the eThekwini Health Unit, Durban, KwaZulu-Natal...

The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US...

We aimed to estimate the individual and joint impact of age, marital status and diagnosis with sexually transmitted infections (STIs) on HIV acquisition among young women at a population level in Durban, KwaZulu-Natal, South Africa. A total of 3,978 HIV seronegative women were recruited for four biomedical intervention trials from 2002-2009. Point...

It is well documented that the mucosal linings of the female genital tract (FGT) usually provides a robust barrier that protects against sexually acquired infections. However, to the best of our knowledge there are limited South African studies that have investigated the association between damage to the mucosal linings and the acquisition of HIV i...

Background Women in sub-Saharan Africa continue to be at greater risk for HIV acquisition than men. Concurrency, viz. multiple sexual partnerships that overlap over time, has been studied as a possible risk factor for HIV transmission. The aim of this study was to identify predictors of perceived male partner concurrency among sexually active, HIV...

Background Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may...

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information T...

Introduction: Limited information is available on the usefulness of the PIMATM analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa. Materials and methods: The study was conducted under the eThekwini Health Unit, Durban, KwaZulu-Na...

. To the best of our knowledge, there have been no published reports on the diagnostic performance of the Chlamydia Rapid Test (CRT) Device for male urine samples. We evaluated the performance of the CRT Device when compared with that of the BD ProbeTec ET PCR Assay in a population of asymptomatic men. Methods . The study enrolled 100 men between J...

In The Lancet Infectious Diseases Elizabeth Byrne and colleagues report the biological mechanism by which injectable progestin-only contraceptives such as depot medroxy progesterone acetate (DMPA) and norethindrone enanthate (NET-EN) or endogenous progesterone might act to increase the risk of HIV acquisition in women. They report that HIV-negative...

Objective: To assess the effect of oral and injectable contraceptive use compared to non-hormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. Study design: Prospective cohort study using data from women enrolled in HIV Prevention Trials Network (HPTN) protocol 035. At each quarterly visit, p...

Unplanned pregnancy rates in South Africa are high. Effective use of contraception is therefore an essential public health intervention to prevent unplanned pregnancies. This study describes contraception use and its impact on pregnancy in women participating in HIV prevention research and its implications for public health practice. A secondary an...

Tuberculosis (TB) remains a global emergency causing an estimated 1.5 million deaths annually. For several decades the major focus of TB treatment has been on antibiotic development targeting Mycobacterium tuberculosis (M.tb). The lengthy TB treatment duration and poor treatment outcomes associated with multi-drug resistant TB (MDR-TB) are of major...

A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women's risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in ≥...

The treatment of tuberculosis is based on combinations of drugs that directly target Mycobacterium tuberculosis. A new global initiative is now focusing on a complementary approach of developing adjunct host-directed therapies.

In South Africa, a large proportion of young women are in age disparate relationships which is believed to be a risk factor for human immunodeficiency virus (HIV). The aim of this study was to determine the generational effect of age disparity on HIV and sexually transmitted infections (STI) incidence. Socio-demographic and behavioural data were co...

This review was designed to evaluate the progress in studies of the use of oral and topical antiretroviral (ARV) medication for primary HIV prevention. Nonhuman primate data have suggested that the administration of ARV medication before or after retroviral exposure can protect against the establishment of chronic infection. Over the past two decad...

While the expansion of antiretroviral therapy (ART) in sub-Saharan Africa has reduced morbidity and mortality from HIV/AIDS, it has increased concern about drug resistance. The Microbicide Trials Network 009 study assessed the prevalence of drug-resistance mutations among women at clinical sites in Durban, South Africa who tested seropositive for H...

Several observational studies have reported that HIV-1 acquisition seems to be higher in women who use depot medroxyprogesterone acetate (DMPA) than in those who do not use hormonal contraception. We aimed to assess whether two injectable progestin-only contraceptives, DMPA and norethisterone enanthate (NET-EN), confer different risks of HIV-1 acqu...

Gender norms that privilege men's sexual power and pleasure, and distrust of condom use in intimate relationships, leave women vulnerable to HIV and other sexually transmitted infections. Vaginal microbicides allow women to exert a degree of control over their sexual health, through responsibility for product insertion as well as the possibility of...

Introduction: Understanding the impact of curable sexually transmitted infections (STIs) on HIV transmissibility is essential for effective HIV prevention programs. Investigating the impact of longitudinally measured recurrent STIs on HIV seroconversion is the interest of the current paper. Methods: In this prospective study, data from a total o...

We evaluated a point of care test for the detection of Neisseria gonorrhoeae in patients attending a public health clinic in KwaZulu-Natal. The test showed a low sensitivity against PCR and culture (<40%), however a higher specificity was observed (>95%). This test in unsuitable as a screening tool for gonorrhoea. Copyright © 2015, American Society...

Emerging evidence from several randomized controlled trials show that antiretroviral-based biomedical HIV prevention interventions are efficacious in preventing HIV if they are taken as directed, and could potentially reduce the number of new HIV infections globally. Strategies such as treatment as prevention and use of oral pre-exposure prophylaxi...