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1.  Alcohol and Other Drug Use during Pregnancy among Women Attending Midwife Obstetric Units in the Cape Metropole, South Africa 
Little is known about the nature and extent of alcohol and other drug (AOD) use among pregnant women in Cape Town, South Africa, despite the very high levels of AOD use in this part of the country. A cross-sectional survey was conducted among pregnant women attending 11 Midwife Obstetric Units (MOUs) in greater Cape Town. A two-stage cluster survey design was used. In total, 5231 pregnant women were screened to assess self-reported prevalence estimates. Of these, 684 (13.1%) were intentionally subsampled and completed an interviewer-administered questionnaire and provided a urine sample for biological screening. Urinalyses showed that 8.8% (95% CI: 6.7–10.9) of the subsample tested positive for at least one illicit drug. This is higher than the self-reported prevalence (3.6%). In addition, 19.6% (95% CI: 16.3–22.8) of the sub-sample tested positive for alcohol which is lower than the self-reported prevalence (36.9%). There are high levels of substance use among pregnant women attending public sector antenatal clinics. There is a need for routine screening for AOD use and appropriate responses depending on the women's level of risk.
doi:10.1155/2014/871427
PMCID: PMC3930165  PMID: 24639899
2.  Promoting sexual and reproductive health among adolescents in southern and eastern Africa (PREPARE): project design and conceptual framework 
BMC Public Health  2014;14:54.
Background
Young people in sub-Saharan Africa are affected by the HIV pandemic to a greater extent than young people elsewhere and effective HIV-preventive intervention programmes are urgently needed. The present article presents the rationale behind an EU-funded research project (PREPARE) examining effects of community-based (school delivered) interventions conducted in four sites in sub-Saharan Africa. One intervention focuses on changing beliefs and cognitions related to sexual practices (Mankweng, Limpopo, South Africa). Another promotes improved parent-offspring communication on sexuality (Kampala, Uganda). Two further interventions are more comprehensive aiming to promote healthy sexual practices. One of these (Western Cape, South Africa) also aims to reduce intimate partner violence while the other (Dar es Salaam, Tanzania) utilises school-based peer education.
Methods/design
A modified Intervention Mapping approach is used to develop all programmes. Cluster randomised controlled trials of programmes delivered to school students aged 12–14 will be conducted in each study site. Schools will be randomly allocated (after matching or stratification) to intervention and delayed intervention arms. Baseline surveys at each site are followed by interventions and then by one (Kampala and Limpopo) or two (Western Cape and Dar es Salaam) post-intervention data collections. Questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of HIV-preventive behaviours. Data from all sites will be merged in order to compare prevalence and associations across sites on core variables. Power is set to .80 or higher and significance level to .05 or lower in order to detect intervention effects. Intraclass correlations will be estimated from previous surveys carried out at each site.
Discussion
We expect PREPARE interventions to have an impact on hypothesized determinants of risky sexual behaviour and in Western Cape and Dar es Salaam to change sexual practices. Results from PREPARE will (i) identify modifiable cognitions and social processes related to risky sexual behaviour and (ii) identify promising intervention approaches among young adolescents in sub-Saharan cultures and contexts.
Trial registrations
Controlled Trials ISRCTN56270821 (Cape Town); Controlled Trials ISRCTN10386599 (Limpopo); Clinical Trials NCT01772628 (Kampala); Australian New Zealand Clinical Trials Registry ACTRN12613000900718 (Dar es Salaam).
doi:10.1186/1471-2458-14-54
PMCID: PMC3908968  PMID: 24438582
3.  Linkage to HIV Care from a Mobile Testing Unit in South Africa by Different CD4 Count Strata 
Background
The linkage and barriers of linkage to facility-based HIV care from a mobile HIV testing unit have not previously been described.
Methods
A stratified random sample (N=192) was drawn of all eligible, newly-diagnosed HIV-infected individuals with a laboratory CD4 count result on a mobile unit between August 2008 and December 2009. All individuals with CD4 counts ≤ 350 cells/μl and 30% of individuals with CD4 counts > 350 cells/μl were sampled. Linkage to care was assessed during April to June 2010 in those that received their CD4 count result. A participant who accessed HIV care at least once after testing was regarded as having linked to care. Binomial regression models were used to identify clinical and socio-demographic factors associated with receiving a CD4 count result and linking to care.
Results
Forty-three (27%) individuals did not receive their CD4 count result. A lower CD4 count, being female and the availability of a phone number increased the likelihood of receiving this result. Follow-up was attempted in the remaining 145 individuals. Ten refused to participate and contact was unsuccessful in 42.4%. Linkage was 100% in patients with CD4 counts ≤ 200 cells/μl, 66.7% in individuals with CD4 counts of 201-350 cells/μl and 36.4% in those with CD4 counts > 350 cells/μl. A lower CD4 count, disclosure, presence of TB symptoms and unemployment increased the likelihood of linking to care.
Conclusion
Linkage to care was best among those eligible for ART. Interventions designed at improving linkage among employed individuals are urgently warranted.
doi:10.1097/QAI.0b013e31822e0c4c
PMCID: PMC3805962  PMID: 21836524
Mobile HIV testing unit; linkage to HIV and ART care; barriers to linkage to HIV care
4.  Condom use and sexuality communication with adults: a study among high school students in South Africa and Tanzania 
BMC Public Health  2013;13:874.
Background
Fostering adolescents’ communication on sexuality issues with their parents and other significant adults is often assumed to be an important component of intervention programmes aimed at promoting healthy adolescent sexual practices. However, there are few studies describing the relationship between such communication and sexual practices, particularly in sub-Saharan Africa. This study examined the relationships between adolescents’ communication with significant adults and their condom use in three sites in this region.
Methods
Data stem from a multi-site randomized controlled trial of a school-based HIV prevention intervention implemented in Cape Town and Mankweng, South Africa and Dar es Salaam, Tanzania. Only data from comparison schools were used. The design is therefore a prospective panel study with three waves of data collections. Data were collected in 2004 from 6,251 participants in 40 schools. Associations between adolescents’ communication with adults about sexuality issues and their use of condoms were analysed cross-sectionally using analysis of variance, as well as prospectively using multiple ordinal logistic regression analysis.
Results
Cross-sectional analyses showed that consistent condom users had significantly higher mean scores on communication (across topics and communication partners) than both occasional users and never-users, who had the lowest scores. After controlling for condom use at the first data collection occasion in each model as well as for possible confounders, communication scores significantly predicted consistent condom use prospectively in all three ordinal logistic regression models (Model R2 = .23 to .31).
Conclusion
The findings are consistent with the assertion that communication on sexuality issues between adolescents and significant adults results in safer sexual practices, as reflected by condom use, among in-school adolescents. The associations between communication variables and condom use might have been stronger if we had measured additional aspects of communication such as whether or not it was initiated by the adolescents themselves, the quality of advice provided by adults, and if it took place in a context of positive adult-adolescent interaction. Studies with experimental designs are needed in order to provide stronger evidence of causality.
doi:10.1186/1471-2458-13-874
PMCID: PMC4016546  PMID: 24053420
Adolescents; Parents; Condom use; Communication; South Africa; Tanzania
5.  Implementing a provider-initiated testing and counselling (PITC) intervention in Cape town, South Africa: a process evaluation using the normalisation process model 
Background
Provider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach.
Method
This longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes.
Results
The new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome.
Conclusion
Leadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the clinical consultation may have contributed to limiting the size of the trial outcomes. A close fit between the PITC intervention design and clinical practices, as well as appropriate training, are needed to ensure sustainability of the programme. The use of a theory-driven analysis promotes transferability of the results, and the findings are therefore relevant to the implementation of HIV testing and to the design and evaluation of complex interventions in other settings.
Trial registration
Current controlled trials ISRCTN93692532
doi:10.1186/1748-5908-8-97
PMCID: PMC3765808  PMID: 23972055
Routine ‘opt-out’ HIV testing; Process evaluation; Normalisation process model; Sexually transmitted infection; Qualitative method
6.  Sexual health, HIV risk, and retention in an adolescent HIV prevention trial preparatory cohort 
Purpose
Adolescents are at high risk for HIV infection, yet have not been included in HIV vaccine trials.
Methods
In preparation for their enrollment in HIV vaccine trials, 100 HIV-negative 14 to 17 year olds from Cape Town were recruited into a cohort. HIV, syphilis, pregnancy testing, and sexual risk questionnaires were performed at varying intervals for one year.
Results
The mean age of the participants was 15 years, and 70% were female. Recruitment was completed in three months. Retention was 82% at 1 year. The main reasons for dropout were relocation to other communities, phlebotomy, and visit frequency. In a Cox proportional hazards model, only female gender was significantly associated with retention. No change in reported sexual risk occurred, but the proportion knowing their partners’ HIV status was significantly higher (17% at baseline, 83% at one year; p<0.001). There were five pregnancies during follow-up.
Conclusions
To our knowledge, this is the first prospective adolescent HIV prevention cohort in Southern Africa. Despite reports of risky sex and high pregnancy rates, HIV seroconversions did not occur in the retained cohort. HIV prevention trials with high-risk adolescents will require rigorous efforts to prevent pregnancy, and may require risk eligibility criteria. Retention may improve with transport provision, incentivizing visits, and efforts to retain males.
doi:10.1016/j.jadohealth.2010.10.009
PMCID: PMC3124666  PMID: 21700155
Adolescents; HIV; sexual risk; retention; cohort
7.  Predicting substance use behavior among South African adolescents: The role of leisure experiences across time 
Using seven waves of data, collected twice a year from the 8th through the 11th grades in a low-resource community in Cape Town, South Africa, we aimed to describe the developmental trends in three specific leisure experiences (leisure boredom, new leisure interests, and healthy leisure) and substance use (cigarettes, alcohol, and marijuana) behaviors and to investigate the ways in which changes in leisure experiences predict changes in substance use behaviors over time. Results indicated that adolescents’ substance use increased significantly across adolescence, but that leisure experiences remained fairly stable over time. We also found that adolescent leisure experiences predicted baseline substance use and that changes in leisure experiences predicted changes in substance use behaviors over time, with leisure boredom emerging as the most consistent and strongest predictor of alcohol, cigarette, and marijuana use. Implications for interventions that target time use and leisure experiences are discussed.
doi:10.1177/0165025411404494
PMCID: PMC3375719  PMID: 22707811
adolescence; boredom; leisure; South Africa; substance use; time use
8.  Changes to the law on consent in South Africa: implications for school-based adolescent sexual and reproductive health research 
Background
The National Health Act, No 61, 2003 in South Africa is the first effort made by the government to protect health-related research participants under law. Implemented on March 1, 2012, the law mandates active consent from a parent or legal guardian for all research conducted with research participants under the age of 18 years. This paper focuses on the Act's implications for school-based adolescent sexual and reproductive health research.
Discussion
Although well intentioned, the added legal protections in the National Health Act may have the unintended consequence of reducing participation rates in school-based adolescent sexual and reproductive health research, thereby excluding the most at-risk students. The Act may also compromise adolescents' right to dignity and privacy, especially considering the personal nature of research on sex and sexuality. Devolved, discretionary decision-making, which empowers local human research ethics committees to permit a wider range of protective measures, including passive consent, independent adolescent consent or community consultation ought to be considered. The continued and direct involvement of young people in their sexual and reproductive health and well-being is an important principle to uphold.
Summary
This paper calls for a re-examination of section 71's ethical guidelines relating to informed consent in the National Health Act, No 61, 2003 in South Africa in order to better serve the interests of South African adolescents in sexual and reproductive health research.
doi:10.1186/1472-698X-12-3
PMCID: PMC3353180  PMID: 22490444
9.  Partner notification 
Clinical Evidence  2009;2009:1605.
Introduction
Many people diagnosed with a sexually transmitted disease (STD) do not have symptoms, and may not inform their past or current sexual partners of their diagnosis, or routinely use condoms. Several strategies have been used to notify and treat partners of people diagnosed with an STD, but only a limited number of RCTs of their effectiveness have been undertaken.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of partner notification strategies in people with different STDs? What are the effects of interventions to improve effectiveness of patient referral in people with STDs? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2008 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 17 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: contract referral, counselling (both alone and in combination with educational interventions) of index patients, educational interventions for the index patient, information for the index patient or partner, outreach assistance, patient referral, patient referral via different types of healthcare professionals, patient-delivered partner therapy, patient-delivered home-sampling kits, provider referral, and reminders (any format) for the index patient.
Key Points
Many people diagnosed with an STD do not have symptoms, and may not inform their past or current sexual partners of their diagnosis, or routinely use condoms.
Several strategies have been used to notify and treat partners of people diagnosed with STDs, but only a limited number of RCTs of their effectiveness have been undertaken.
Patient referral is where the index patient is encouraged to inform their past and present partners.
Provider referral is where health professionals notify the partner without disclosing the identity of the index patient, and outreach assistance is where members of an outreach team indigenous to the community notify the partner without disclosing the identity of the index patient.
Contract referral is where the index patient is encouraged to notify their partners, but the health professional does so if they fail to attend for treatment within an allotted time.
Various methods are used to improve patient referral, including: patient-delivered partner therapy; home sampling kits; information, education, reminders, and counselling for the index patient; and the use of different healthcare professionals.
Contract referral may lead to more partners of people with HIV infection being notified compared with patient referral alone. We don't know whether provider referral or outreach assistance are beneficial in tracing partners of people with HIV.
Contract referral may increase the proportion of partners presenting for treatment compared with patient referral in people with gonorrhoea. We don't know whether either provider referral or outreach assistance are effective partner notification strategies in people with gonorrhoea.
Provider referral may increase the proportion of partners treated compared with patient referral in people with chlamydia. We don't know whether either contract referral or outreach assistance are effective partner notification strategies in people with chlamydia.
Contract referral strategies seem to be as effective as provider referral in people with syphilis, with similar proportions of partners of people with syphilis being notified with each strategy. We don't know whether either patient referral or outreach assistance are effective partner notification strategies in people with syphilis.
Supplementing patient referral with patient-delivered partner therapy may reduce the risk of persistent or recurrent infection in index patients with chlamydia or gonorrhoea. Supplementing patient referral with patient-delivered partner therapy seems to improve the proportion of partners elicited who received treatment compared with supplementation with written information for partners in people with chlamydia or gonorrhoea infections.
In people with chlamydia, home-sampling kits for partners seem to increase the number of partners who are tested for infection compared with simple patient referral.
We don't know whether supplementing patient referral with health education or counselling, either alone or in combination, for index patients improves the number of partners tested or treated.
We don't know whether adding telephone reminders plus counselling, reminders for the index patient, or information pamphlets to patient referral improves partner notification rates, or whether different health professionals are more effective at improving patient referral rates.
PMCID: PMC2907794  PMID: 21733200
10.  The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field 
Background
The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa.
Methods
The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3rd generation ELISA patients identified among those who were rapid test negative at the clinic.
Results
In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation.
Conclusions
Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use.
doi:10.1186/1472-6963-10-73
PMCID: PMC2851712  PMID: 20307310
11.  Partner notification for the control of sexually transmitted infections 
BMJ : British Medical Journal  2007;334(7589):323.
Assisting patients in disclosing their diagnosis to partners is the biggest priority
doi:10.1136/bmj.39114.635405.80
PMCID: PMC1801013  PMID: 17303839
12.  The impact of provider-initiated (opt-out) HIV testing and counseling of patients with sexually transmitted infection in Cape Town, South Africa: a controlled trial 
Background
The effectiveness of provider-initiated HIV testing and counseling (PITC) for patients with sexually transmitted infection (STI) in resource-constrained settings are of particular concern for high HIV prevalence countries like South Africa. This study evaluated whether the PITC approach increased HIV testing amongst patients with a new episode of sexually transmitted infection, as compared to standard voluntary counseling and testing (VCT) at the primary care level in South Africa, a high prevalence and low resource setting.
Methods
The design was a pragmatic cluster-controlled trial with seven intervention and 14 control clinics in Cape Town. Nurses in intervention clinics integrated PITC into standard HIV care with few additional resources, whilst lay counselors continued with the VCT approach in control clinics. Routine data were collected for a six-month period following the intervention in 2007, on new STI patients who were offered and who accepted HIV testing. The main outcome measure was the proportion of new STI patients tested for HIV, with secondary outcomes being the proportions who were offered and who declined the HIV test.
Results
A significantly higher proportion of new STI patients in the intervention group tested for HIV as compared to the control group with (56.4% intervention versus 42.6% control, p = 0.037). This increase was achieved despite a significantly higher proportion intervention group declining testing when offered (26.7% intervention versus 13.5% control, p = 0.0086). Patients were more likely to be offered HIV testing in intervention clinics, where providers offered the HIV test to 76.8% of new STI patients versus 50.9% in the control group (p = 0.0029). There was significantly less variation in the main outcomes across the intervention clinics, suggesting that the intervention also facilitated more consistent performance.
Conclusions
PITC was successful in three ways: it increased the proportion of new STI patients tested for HIV; it increased the proportion of new STI patients offered HIV testing; and it delivered more consistent performance across clinics. Recommendations are made for increasing the impact and feasibility of PITC in high HIV prevalence and resource-constrained settings. These include more flexible use of clinical and lay staff, and combining PITC with VCT and other community-based approaches to HIV testing.
Trial registration
Controlled trial ISRCTN93692532
doi:10.1186/1748-5908-5-8
PMCID: PMC2825497  PMID: 20205841
13.  Community perspectives on the ethical issues surrounding adolescent HIV vaccine trials in South Africa 
Vaccine  2008;26(45):5679-5683.
Summary
Adolescents globally are at high risk for HIV acquisition and are the targets of HIV prevention interventions such as HIV vaccines. In order to understand stakeholders’ attitudes towards the ethical issues of adolescent involvement in HIV vaccine trials, we conducted focus group discussions with key members of a semi-urban, informal Cape Town community with high HIV prevalence in which HIV vaccine trials are taking place. Themes were identified from focus group transcripts by four researchers, and included necessity of guardian consent, age of independent consent, and confidentiality of in-trial medical results. In general, ethical adolescent HIV vaccine trials will be feasible in this community.
doi:10.1016/j.vaccine.2008.08.033
PMCID: PMC2590661  PMID: 18782594
Adolescents; HIV vaccine trials; community; ethics

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