Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

Background

South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits.

Experience

Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and referral for chronic illnesses). Social benefits included training of home-based caregivers and sustainable ongoing HIV prevention education through peer educator programmes.

Challenges

Several challenges were encountered, including manipulation by participants of their eligibility criteria in order to enroll in the trial. Women attempted to co-enroll in multiple trials to benefit from financial reimbursements and individualised care. The trials became ethically challenging when participants refused to take up referrals for care due to stigma, denial of their HIV status and inadequate health infrastructure. Lack of disclosure of HIV status to partners and family members was particularly challenging. Some of the ethical dilemmas put to the test our responsibility as researchers and our obligation to provide health care to research participants.

Conclusion

Conducting these five trials in a period of six years provided us with invaluable insights into trial implementation, community participation, recruitment and retention, provision of care and dissemination of trial results. The critical mass of scientists trained as clinical trialists will continue to address the relentless HIV epidemic in our setting and ensure our commitment to finding a biomedical HIV prevention option for women in the future.     

Clinical research with topical microbicides as a potential HIV prevention method

An overview of the different phases in microbicide research is given with special attention to nonoxynol-9, the only ingredient that has been tested in phase III trials so far. The methodological and ethical challenges in conducting phase III studies are described. These include study population, compliance data, standardization, therapy for HIV-positive women, and informed consent. Despite these challenges, phase III trials are feasible and should be initiated now.     

Barriers and facilitators to HIV testing in primary care among health care providers

PurposeHuman immunodeficiency virus (HIV) is a preventable disease that can have improved outcomes with early diagnosis and treatment. The CDC recommends that HIV testing be incorporated into clinical settings as part of routine medical care.MethodsIndividual, open-ended interviews were conducted with primary care providers and administrators to obtain their views regarding the meaning of routine HIV testing and the barriers and facilitators to implementing routine HIV testing in their respective practices.ResultsMost respondents supported routine HIV testing, although their definitions of roufine varied. Barriers for providers included time and financial constraints to appropriately conduct HIV counseling and testing and inadequate HIV education and training. Facilitators for implementing routine HIV testing included patients' feelings of empowerment and reduced HIV stigma.ConclusionsThe implementation of routine HIV testing in primary care practices appears to be an acceptable public health intervention. Next steps should include efforts to standardize the definition of routine HIV testing and working with primary care settings to better understand and reduce barriers to routine testing.     

Using objective markers to assess participant behavior in HIV prevention trials of vaginal microbicides

The need to verify participant behavior exists in any study in which behavior may affect outcomes. In vaginal microbicide trials, the act of having sex and the use of study products and condoms all affect the risk of acquiring HIV/sexually transmitted infections (STIs). Until now, these behaviors have been assessed using self-reports. But self-reports are limited by participant cooperation in answering questions, imperfect recall, and social desirability biases. Biomarkers are increasingly being used in medicine to reduce the time and resources needed to bring a drug to market. The use of biomarkers in vaginal microbicide trials has been proposed as a means of assessing factors that affect the risk of sexual acquisition of HIV/STIs, namely, the presence of preexisting infection, cervicovaginal inflammation, and the presence of HIV/STIs. Biomarkers for some of these already exist. What are needed are validated markers of behaviors that might affect risk, namely, markers for sexual behavior and for the use of study products and condoms. Validating and working out the logistics of collecting such markers in large trials will be a challenge. But finding objective markers for behavior may help improve adherence measurement during a trial and is a rate-limiting step in the field of vaginal microbicides. Resources and funding should be mobilized to develop and validate markers of sexual behavior and product use as a high priority in vaginal microbicide research.     

Involving behavioral scientists, health care providers, and HIV-infected patients as collaborators in theory-based HIV prevention and antiretroviral adherence interventions

Health care providers are often hesitant to attempt health behavior change interventions with patients, although such interventions are frequently needed. When provider-initiated health behavior change interventions are attempted, they are often based on intuition or consist solely of delivering information and are insufficient to change behavior, rather than being based on well-validated and effective behavior change models. We argue that provider-initiated health behavior change interventions are effective and efficient if they are based on appropriate empirically validated theoretical models and developed in collaboration with behavioral scientists and patients. We present a new model for developing such collaborative interventions and initial evidence for its success.     

Knowledge and perception of microbicides among healthcare providers in Calabar,Nigeria

Background

With the worldwide spread of HIV/AIDS, the absence of a known cure and the challenges associated with existing prevention methodologies, there is need for new prevention technologies. The successful uptake of healthcare products and services depend, to a large extent, on healthcare providers'' knowledge, perception and attitude regarding them.

Objectives

To determine the knowledge and perception of healthcare providers regarding microbicides.

Methods

A semi-structured questionnaire was administered on 400 randomly selected health care providers in Calabar, Cross River State of Nigeria. Data obtained from the 350 returned questionnaire were analyzed using EPI -Info software version 3.5.1

Results

One hundred and sixty-four (46.9%) respondents were medical doctors while 157 (44.9%) were nurses, 7 (2%) were Pharmacists and 22 (6.2%) belonged to “other” categories. Thirty- two percent knew the advantages of microbicides over condoms. Sixty-eight percent indicated that microbicides would benefit only women while to 27%, it would benefit both men and women. Seventy-five percent of respondents would be willing to act as community advocates for microbicides while 21% would not be willing and 4% were not decided. There was a statistically significant association between professional group and willingness to act as community advocates for microbicides. Medical doctors were more likely to act as advocates than other professional groups (p<0.05). Female respondents were more likely to have correct knowledge regarding microbicides than males (p<0.05)

Conclusion

There are gaps in knowledge regarding microbicides among the health care providers. Capacity building would be successful since the majority are willing to act as community advocates.     

Mixed-strain Mycobacterium tuberculosis infections among patients dying in a hospital in KwaZulu-Natal, South Africa

We performed spoligotyping and 24-locus mycobacterial interspersed repetitive-unit-variable-number tandem-repeat (MIRU-VNTR) typing on M. tuberculosis culture-positive biopsy specimens collected from adults dying in a hospital in KwaZulu-Natal. Of 56 culture-positive samples genotyped, we detected mixed strains in five (9%) and clonal heterogeneity in an additional four (7%).     

Prevalence and associated risk factors of low back pain among users of a primary health care clinic serving semi-urban and rural settlements in KwaZulu-Natal,South Africa

BackgroundLow back pain (LBP) is one of the most frequent musculoskeletal conditions and a common work-related health problem. In South Africa, people from lower socio-economic strata are involved in physical labour and also have unequal access to health services. There is minimal data on the prevalence of LBP in these communities. This study determined the prevalence and associated risk factors of LBP among public sector health care users in a semi-urban/rural area of KwaZulu-Natal, South Africa.MethodsThe study was conducted at a primary health care clinic in the Umdoni municipality, KwaZulu-Natal, South Africa. Convenience sequential sampling was used. An interviewer-administered questionnaire was utilized due to literacy constraints. Participants (n=400) answered the questionnaire in either English or isiZulu.ResultsThe lifetime prevalence of LBP was 79.3%. Female gender and lifting heavy objects were associated with LBP. The direct impact of LBP was faced in the work place resulting in absenteeism, often followed by unemployment.ConclusionIn this setting, where the prevalence of LBP was high, specialized treatments for LBP were not available at the primary health care facility. Incorporation of such treatments will be useful, for people in lower socio-economic strata, to overcome the burden of LBP.     

Risk compensation in HIV prevention: Implications for vaccines, microbicides, and other biomedical HIV prevention technologies

Studies investigating the effects of biologic HIV prevention technologies have been reported with promising results for slowing the spread of the disease. Although they can reduce the rate of HIV transmission at varying levels of efficaciousness, it is vital to anticipate their impact on subsequent sexual behaviors. Risk homeostasis theory posits that decreases in perceived risk, which will occur with access to HIV prevention technologies, will correspond with increases in risk-taking behavior. Here we review the literature on risk compensation in response to HIV vaccines, topical microbicides, antiretroviral medications, and male circumcision. Behavioral risk compensation is evident in response to prevention technologies that are used in advance of HIV exposure and at minimal personal cost. We conclude that behavioral risk compensation should be addressed by implementing adjunct behavioral risk-reduction interventions to avoid negating the preventive benefits of biomedical HIV prevention technologies.     

Socio-economic status as predictors of malaria transmission in KwaZulu-Natal,South Africa. A retrospective study

BackgroundUnderstanding the socioeconomic status that influences malaria transmission in KwaZulu-Natal, South Africa is vital in creating policies and strategies to combat malaria transmission, improve socioeconomic conditions and strengthen the malaria elimination campaign.ObjectivesTo determine the relationship between socioeconomic status and malaria incidence in KwaZulu-Natal, South Africa.MethodsSocioeconomic information (gender, age, no formal education, no electricity, no toilet facilities, unemployment) and malaria data for 2011 were obtained from Statistics South Africa and the malaria control program of KwaZulu-Natal, South Africa respectively. The analysis was conducted employing the Bayesian multiple regression model.ResultsThe obtained posterior samples show that all the variables employed in this study were significant and positive predictors of malaria disease at 95% credible interval. The low socioeconomic status that exhibited the strongest association with malaria risk was lack of toilet facilities (odd ratio =12.39; 95% credible interval = 0.61, 24.36). This was followed by no formal education (odd ratio =11.11; 95% credible interval = 0.51, 24.10) and lack of electricity supply (odd ratio =8.94; 95% credible interval = 0.31, 23.21) respectively.ConclusionsLow socioeconomic status potentially sustains malaria transmission and burden. As an implication, poverty alleviation and malaria intervention resources should be incorporated side by side into the socioeconomic framework to attain zero malaria transmission.     

Patients Consulting Traditional Health Practioners in the Context of HIV/AIDS in Urban Areas in KwaZulu-Natal, South Africa

The purpose of this study is to assess patients consulting full-time traditional health practitioners (THPs) and the practice of THPs after they had been trained on Human Immunodeficiency Virus (HIV)/ Sexually Transmitted Infections (STI) prevention and care. The sample included 222 patients interviewed when exiting a THP''s practice (n=17) in purposefully chosen two urban sites in KwaZulu-Natal. Results indicate that at post training evaluation the majority of the THPs were involved in HIV/STI management and most had low levels of HIV risk practices at the workplace. Major self-reported reasons for consulting the THP included a complex of supernatural or psychosocial problems, chronic conditions, acute conditions, generalized pain, HIV and other STIs. Overall, patients including HIV positive (n=18) patients had moderate knowledge of Antiretroviral Therapy (ART). A number of HIV positive patients were using traditional medicine and ART concurrently, dropped out of ART because of side effects and were using traditional medicine for HIV.     

Modelling CD4 counts before and after HAART for HIV infected patients in KwaZulu-Natal South Africa

BackgroundThis study aims to make use of a longitudinal data modelling approach to analyze data on the number of CD4+cell counts measured repeatedly in HIV-1 Subtype C infected women enrolled in the Acute Infection Study of the Centre for the AIDS Programme of Research in South Africa.MethodologyThis study uses data from the CAPRISA 002 Acute Infection Study, which was conducted in South Africa. This cohort study observed N=235 incident HIV-1 positive women whose disease biomarkers were measured repeatedly at least four times on each participant.ResultsFrom the findings of this study, post-HAART initiation, baseline viral load, and the prevalence of obese nutrition status were found to be major significant factors on the prognosis CD4+ count of HIV-infected patients.ConclusionEffective HAART initiation immediately after HIV exposure is necessary to suppress the increase of viral loads to induce potential ART benefits that accrue over time. The data showed evidence of strong individual-specific effects on the evolution of CD4+ counts. Effective monitoring and modelling of disease biomarkers are essential to help inform methods that can be put in place to suppress viral loads for maximum ART benefits that can be accrued over time at an individual level.