Persistence and clearance of high-risk human papillomavirus and cervical dysplasia at 1 year in women living with human immunodeficiency virus: a prospective cohort study.

OBJECTIVE: Evaluate 1-year outcomes of cervical cancer screening and treatment using primary high-risk human papillomavirus (HPV) testing in women living with human immunodeficiency virus (HIV). DESIGN: Prospective cohort study. SETTING: HIV treatment centre in Botswana. POPULATION: Women living with HIV. METHODS: Participants underwent cervical cancer screening with high-risk HPV testing and triage evaluation at baseline and 1-year follow up. Excisional treatment was offered as indicated. Histopathology was the reference standard. MAIN OUTCOME MEASURES: Persistence, clearance and incidence of high-risk HPV infection; and persistence, progression, regression, cure and incidence of cervical dysplasia. RESULTS: Among 300 women screened at baseline, 237 attended follow up (79%). High-risk HPV positivity significantly decreased from 28% at baseline to 20% at 1 year (P = 0.02). High-risk HPV persistence was 46% and clearance was 54%; incidence was high at 9%. Prevalence of cervical intraepithelial neoplasia Grade 2 (CIN2) or higher was most common in participants with incident high-risk HPV (53%). CIN2 or higher was also common in those with persistent high-risk HPV (32%) and even in those who cleared high-risk HPV (30%). Of the high-risk HPV-positive participants at baseline with

Migration of etonogestrel contraceptive implants: Implications for difficult removals services need in southern Africa.

The first difficult contraceptive implant removals clinic in sub-Saharan Africa was started 2 years ago at New Somerset Hospital in Cape Town, South Africa, and has seen two cases of implant migration. We report these cases here. The first was a case of fascial migration and the second one of migration via the cephalic vein, both to a site just anterior to the glenohumeral joint. Both implants were removed without complications. Even with correct insertion technique, migrations can occur. Healthcare providers need to know how to manage difficult removals, and how to access and refer to difficult removals services when necessary. These services must therefore be available in all settings where implants are offered, to ensure access to rights-based family planning services for all women in southern Africa.

Modified early warning score predicts the need for hospital admission and inhospital mortality.

BACKGROUND: The modified early warning score (MEWS) is a useful tool for identifying hospitalised patients in need of a higher level of care and those at risk of inhospital death. Use of the MEWS as a triage tool to identify patients needing hospital admission and those at increased risk of inhospital death has been evaluated only to a limited extent. AIM: To evaluate the use of the MEWS as a triage tool to identify medical patients presenting to the emergency department who require admission to hospital and are at increased risk of inhospital death. METHODS: Physiological parameters were collected from 790 medical patients presenting to the emergency department of a public hospital in Cape Town, South Africa. MEW scores were calculated from the data and multivariate regression analysis was performed to identify independent predictors of hospital admission and inhospital mortality. RESULTS: The proportion of patients admitted and those who died in hospital increased significantly as the MEW score increased (p<0.001). Multivariate regression analysis identified five independent predictors of hospital admission: systolic blood pressure < or =100 mm Hg, pulse rate > or =130 beats per minute, respiratory rate > or =30 breaths per minute, temperature > or =38.5 degrees C and an impaired level of consciousness. Independent predictors of inhospital death were: abnormal systolic blood pressure (< or =100 or > or =200 mm Hg), respiratory rate > or =30 breaths per minute and an impaired level of consciousness. CONCLUSION: The MEWS, specifically five selected parameters, may be used as a rapid, simple triage method to identify medical patients in need of hospital admission and those at increased risk of inhospital death.

Rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in South Africa and Vietnam: a randomised controlled equivalence trial.

BACKGROUND: We assessed whether the safety of first-trimester manual vacuum aspiration abortion done by health-care providers who are not doctors (mid-level providers) is equivalent to that of procedures done by doctors in South Africa and Vietnam, where mid-level providers are government trained and accredited to do first-trimester abortions. METHODS: We did a randomised, two-sided controlled equivalence trial to compare rates of complication in abortions done by the two groups of providers. An a-priori margin of equivalence of 4.5% with 80% power and 95% CI (alpha=0.05) was used. 1160 women participated in South Africa and 1734 in Vietnam. Women presenting for an induced abortion at up to 12 weeks' gestation were randomly assigned to a doctor or a mid-level provider for manual vacuum aspiration and followed-up 10-14 days later. The primary outcome was complication of abortion. Complications were recorded during the abortion procedure, before discharge from the clinic, and at follow-up. Per-protocol and intention-to-treat analyses were done. This trial is registered at with the identifier . FINDINGS: In both countries, rates of complication satisfied the predetermined statistical criteria for equivalence: rates per 100 patients in South Africa were 1.4 (eight of 576) for mid-level providers and 0 for doctors (difference 1.4, 95% CI 0.4 to 2.7); in Vietnam, rates were 1.2 (ten of 824) for mid-level providers and 1.2 (ten of 812) for doctors (difference 0.0, 95% CI -1.2 to 1.1). There was one immediate complication related to analgesics. Delayed complications were caused by retained products and infection. INTERPRETATION: With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.

User perspectives on Implanon NXT in South Africa: A survey of 12 public-sector facilities

Abstract: Background. Implanon NXT, a long-acting reversible contraceptive, was introduced in South Africa (SA) in early 2014, aiming to expand the method mix and increase its effectiveness. Initial uptake was high, but has since declined considerably. In these early years after the implant's introduction, it is important to identify reasons for the decline, and remedy gaps in services. Objectives. To determine periods of use, reasons for the use and early removal of the implant Implanon NXT. Methods. In 2016, we recruited 152 women from six clinics in the City of Johannesburg, and six in North West Province, SA. A semistructured interview was administered to 91 women currently using the implant and 61 previous users. We examined user perspectives, factors influencing women's experiences with the implant and reasons for discontinuation. Results. The participants' mean age was 30 years, with only 15% aged <25. Implant uptake was motivated by convenience (less frequent visits required than for short-acting methods) and by favourable views of the method among friends, family and healthcare providers. Only about a quarter of women recalled being counselled pre-insertion about implant effectiveness, and half about side-effects pre-insertion. Among discontinuers, the median time to device removal was 8 months (interquartile range 6 - 12), and this was primarily as a result of side-effects (90%), especially bleeding-pattern changes and headaches. Removals were most common among married and cohabiting women, often ascribed to the effects of bleeding on their sexual relationships. Rumours and misinformation contributed to some removals. Overall, women's experiences with the implant were rated 'good' or 'very good' by 74% of those continuing use, many of whom reported not having experienced any side-effects or that these had diminished over time. Conclusion. Levels of acceptability among continuing users were high, mainly linked to the method's convenience. While early favourable views drove uptake, negative perceptions, if unaddressed, may now undermine services. Deficiencies in counselling around effectiveness and side-effects may extend to contraceptive services more generally. Women require more intensive support when experiencing sideeffects, including effective systematic approaches to ameliorating bleeding and headaches. Implant services could specifically target young women and first-time contraceptive users. These actions together could reverse the persistent decline in implant use in SA.

Uptake and early removals of Implanon NXT in South Africa: Perceptions and attitudes of healthcare workers

Background. The South African (SA) government introduced Implanon NXT, a long-acting subdermal contraceptive implant, in 2014 to expand contraceptive choice. Following an initial high uptake, its use declined considerably amid reports of early removals and frequent side-effects. We examine providers' perceptions of training and attitudes towards Implanon NXT, as well as their views on the causes of early removals and the impact on the implant service. Objective. To assess healthcare providers' perceptions and attitudes towards implant services in SA. Methods. In-depth interviews were conducted with eight nurses providing implant services in public facilities in Gauteng and North West Province. Emerging themes were identified, manually coded and thematically analysed following an interpretivism approach. Results. Nurses lacked confidence in providing implant services effectively, particularly removals, which they ascribed to the brief, cascade-type training received. Nurses generally held negative views towards the method. They also reported that side-effects are the most common reason for early removals ­ particularly irregular bleeding ­ and that men often do not support their partners who use the method. Lastly, it was found that providers require guidance on counselling regarding the method and standardised guidelines on the management of side-effects. Conclusion. Retraining and support of providers are needed to address competency gaps and negative attitudes towards the method. Assessment of providers' readiness to perform removal procedures is also important. Finally, effective plans are necessary to improve implant continuation rates, especially among women whose partners are unsupportive.

Gaps in monitoring systems for Implanon NXT services in South Africa: An assessment of 12 facilities in two districts

Background. Implanon NXT, a long-acting subdermal contraceptive implant, was introduced in South Africa (SA) in early 2014 as part of an expanded contraceptive method mix. After initial high levels of uptake, reports emerged of frequent early removals and declines in use. Monitoring of progress and challenges in implant service delivery could identify aspects of the programme that require strengthening. Objectives. To assess data management and record keeping within implant services at primary care facilities. Methods. We developed a checklist to assess the tools used for monitoring implant services and data reporting to district offices. The checklist was piloted in seven facilities. An additional six high-volume and six low-volume implant insertion clinics in the City of Johannesburg (CoJ), Gauteng Province, and the Dr Kenneth Kaunda District, North West Province, were selected for assessment. Results. All 12 facilities completed a Daily Head Count Register, which tallied the number of clients attending the clinic, but not information about implant use. A more detailed Tick Register recorded services that clinic attendees received, with nine documenting number of implant insertions and six implant removals. A more specific tool, an Insertion Checklist, collected data on insertion procedures and client characteristics, but was only used in CoJ (five of six facilities). Other registers, which were developed de novo by staff at individual facilities, captured more detailed information about insertions and removals, including reasons. Five of six low-volume insertion facilities used these registers, but only three of six high-volume facilities. No facilities used the form specifically developed by the National Department of Health for implant pharmacovigilance. Nine of 12 clinics reported data on numbers of insertions to the district office, six reported removals and none provided data on reasons for removals. Conclusion. For data to inform effective decision-making and quality improvement in implant services in SA, standardised reporting guidelines and data collection tools are needed, reinforced by staff training and quality assessment of data collection. Staff often took the initiative to fill gaps in reporting systems. Current systems are unable to accurately monitor uptake or discontinuation, or identify aspects of services requiring strengthening. Lack of pharmacovigilance data is especially concerning. Deficiencies noted in these monitoring systems may be common to family planning services more broadly, which warrants investigation.

Lessons learnt from the introduction of the contraceptive implant in South Africa

In 2014, South Africa (SA) introduced the subdermal contraceptive implant with the aim of expanding the contraceptive method mix and availability of long-acting reversible methods in the public sector. Three years on, concerns have been raised about the decline in uptake, early implant removals and challenges in service delivery. This article explores the lessons learnt from the introduction of contraceptive technologies elsewhere and applies these to the SA context. Drawing on the World Health Organization's conceptual framework for the introduction of new contraceptive methods, and subsequent literature on the topic, lessons are classified into six cross-cutting themes. Recommendations highlight the need for SA to review and explore strategies to strengthen current implant services, including the provision of improved provider training aimed at sensitive, client-centred approaches; increased community engagement; and improved systems for programmatic monitoring and evaluation. With implementation of these recommendations, worrying trends in the provision of implants could be reversed.

Diagnosing smear-negative tuberculosis using case definitions and treatment response in HIV-infected adults.

OBJECTIVE: To assess the diagnostic utility of expanded case definitions for HIV-associated smear-negative pulmonary tuberculosis (PTB) and extra-pulmonary TB (EPTB), and to derive objective criteria for response to anti-tuberculosis treatment. DESIGN: A prospective cohort study of HIV-infected adults who met expanded clinical case definitions for smear-negative PTB and EPTB. METHODS: All participants were started on rifampicin-based anti-tuberculosis treatment after mycobacterial cultures from multiple sites. At weeks 2, 4 and 8, response to treatment (RTT) was assessed by measuring changes in weight, haemoglobin, C-reactive protein, Karnofsky performance score and symptom count ratio. RESULTS: Of 147 participants enrolled, 105 (71%) were diagnosed with definite (culture-positive) or probable (histological features) TB and 25 (17%) with possible TB (treatment response). The positive predictive value for the most common case definitions ranged from 89% to 96%. Significant improvements in all the RTT parameters occurred in the subjects with confirmed TB (P < 0.001). Clinically relevant RTT criteria were derived, two or more of which were met at week 8 in 97.5% of subjects with confirmed TB, 91.3% of subjects with possible TB and none of the subjects without TB. CONCLUSION: Expanded case definitions could enhance the diagnosis of PTB and EPTB in HIV-infected adults in resource-limited settings. Using objective criteria, RTT can be assessed within 8 weeks of initiating anti-tuberculosis treatment.

Outcome of AIDS-associated cryptococcal meningitis initially treated with 200 mg/day or 400 mg/day of fluconazole.

BACKGROUND: AIDS-associated cryptococcal meningitis has a high mortality. Fluconazole was the only systemic antifungal therapy available in our centre. From 1999-2001 we used low-dose fluconazole (200 mg daily initially), and did not offer therapy to patients perceived to have poor prognoses. In 2001 donated fluconazole became available, allowing us to use standard doses (400 mg daily initially). Antiretroviral therapy was not available during the study period. METHODS: Retrospective chart review of adult patients before and after the fluconazole donation. RESULTS: 205 patients fulfilled the inclusion criteria, 77 before and 128 after the donation. Following the donation fewer patients received no antifungal treatment (5% vs 19%, p = 0.002), and more patients received standard-dose fluconazole (90% vs 6%, p < 0.001). In-hospital mortality was 25%. Impaired consciousness, no antifungal treatment received and cerebrospinal fluid antigen titre > 1,000 were independent predictors of in-hospital mortality. Concomitant rifampicin did not affect in-hospital survival. Thirteen patients were referred to the tertiary referral hospital and received initial treatment with amphotericin B for a mean of 6 days - their in-hospital survival was not different from patients who received only fluconazole (p = 0.9). Kaplan-Meier analysis showed no differences in length of survival by initial treatment with standard or low doses of fluconazole (p = 0.27 log rank test); median survival was 76 and 82 days respectively. CONCLUSION: Outcome of AIDS-associated cryptococcal meningitis is similar with low or standard doses of fluconazole. The early mortality is high. Initial therapy with amphotericin B and other measures may be needed to improve outcome.

Depot medroxyprogesterone versus norethisterone oenanthate for long-acting progestogenic contraception.

BACKGROUND: There are two injectable progestogen-only contraceptives (IPCs) that have been available in many countries in the world since 1983. They are both still extensively used in many developing countries, forming a large proportion of the health system's expenditure on contraception. These are depot medroxyprogesterone acetate (DMPA) and norethisterone oenanthate (NET-EN). These are both highly effective contraceptives that receive wide acceptance amongst women in their fertile years. They differ in frequency of administration that has implications on patient uptake. They also differ in cost that may significantly affect budgeting in the health system. A systematic comparison will aid to ensure their rational use. OBJECTIVES: To determine if there are differences between depot medroxyprogesterone acetate given at a dose of 150 mg IM every 3 months and norethisterone oenanthate given at a dose of 200mg IM every 2 months, in terms of contraceptive effectiveness, reversibility and discontinuation patterns, minor effects and major effects. SEARCH STRATEGY: We searched the computerized databases MEDLINE using PubMed, Popline, Cochrane Controlled Trials Register, Biblioline, LILACS, EMBASE and PASCAL for randomised controlled trials of DMPA versus NET-EN for long-acting progestogenic contraception. Studies were included regardless of language, and all databases were reviewed from the time that injectable progestogens have been in use. SELECTION CRITERIA: All randomised controlled comparisons of DMPA acetate given at a dose of 150 mg IM every 3 months versus NET-EN given at a dose of 200mg IM every 2 months, used for contraception, were included. Trials had to report on contraceptive efficiency and return to fertility, discontinuation risks and reasons for discontinuation, and clinical effects, both menstrual and non-menstrual. DATA COLLECTION AND ANALYSIS: BD and CM evaluated the titles and abstracts obtained through applying the search strategy and applied the eligibility criteria. BD attempted to contact authors where clarification of the data was required, and contacted all main manufacturers of the contraceptives. After inclusion of the two studies, the data was abstracted and analysed with RevMan 4.2. MAIN RESULTS: Two trials were included in this review. There was no significant difference between the two treatment groups for the frequency of discontinuation for either contraceptive, although the women on NET-EN were 4% more likely to discontinue for personal reasons than those on DPMA. Discontinuation because of accidental pregnancy did not differ between the groups. Although the duration of bleeding and spotting events was the same in each group, women on DPMA were 21% more likely to develop amenorrhoea. Mean changes in body weight at 12 and 24 months, and in systolic and diastolic blood pressure at 12 months did not differ significantly between the studies. AUTHORS' CONCLUSIONS: While the choice between DPMA and NET-EN as injectable progestogen contraceptives may vary between both health providers and patients, data from randomized controlled trials indicate little difference between the effects of these methods, except that women on DMPA are more likely to develop amenorrhoea. There is inadequate data to detect differences in some non-menstrual major and minor clinical effects.

Emergency contraception in South Africa: knowledge, attitudes, and use among public sector primary healthcare clients.

To determine knowledge of, attitudes toward, and use of emergency contraception (EC), interviews were held with 1068 clients of 89 public sector primary healthcare facilities in two urban and two rural areas of South Africa. Only 22.8% of the clients had heard of EC. Awareness was significantly lower in the most rural area and among older, less educated women. Knowledge of EC was superficial, with 47.1% unsure of the appropriate interval between unprotected intercourse and starting EC and 56.6% not knowing whether it was available at the clinic. Few (9.1%) of those who knew of EC had used it. After explaining EC, attitudes toward its use were found to be positive, with 90.3% indicating that they would use it if needed. Awareness was lower than in developed countries, but higher than in other developing countries. Findings indicate that if women know of EC, where to get it, and how soon to take it, they would use it if needed.

Evaluation of the World Health Organization algorithm for the diagnosis of HIV-associated sputum smear-negative tuberculosis.

BACKGROUND: Outcomes from the World Health Organization's (WHO's) recommendations for the diagnosis of smear-negative tuberculosis (SNTB) in high human immunodeficiency virus prevalence settings are unknown. METHODS: We retrospectively applied the WHO algorithm for SNTB without danger signs to a prospectively enrolled cohort of ambulatory adult SNTB suspects in KwaZulu-Natal, South Africa. Participants fulfilling specified criteria for SNTB started empiric anti-tuberculosis treatment; the rest of the cohort was observed. All were followed for 8 weeks. Confirmed TB was defined as positive culture or granulomata plus acid-fast bacilli on histology. RESULTS: In total, 221 participants retrospectively fulfilled the WHO ambulatory SNTB algorithm entry criteria. The diagnostic performance of the WHO algorithm was: positive predictive value 0.34 (95%CI 0.26-0.43), negative predictive value 0.86 (95%CI 0.76-0.92), positive likelihood ratio 1.43 (95%CI 1.34-1.48), negative likelihood ratio 0.46 (95%CI 0.38-0.56) and diagnostic odds 3.1 (95%CI 1.52-6.34). Losses to follow-up (n = 4), hospitalisations (n = 6) and deaths (n = 5) did not differ significantly in those who were and were not diagnosed with SNTB. CONCLUSIONS: The WHO ambulatory SNTB algorithm had a reasonably high negative predictive value but low positive predictive value. Mortality over an 8-week period was low in participants who met the entry criteria for the WHO algorithm.

Community attitudes towards sexual activity and childbearing by HIV-positive people in South Africa.

While the ability to lead a healthy sexual life and to choose whether and when to have children are well-established features of reproductive health and human rights, issues surrounding sexual activity and childbearing among HIV-infected women and men have received little attention in sub-Saharan Africa. We conducted a semi-structured, cross-sectional survey at 26 primary health care clinics in South Africa to investigate community attitudes towards sexual activity and reproduction by HIV-infected individuals. Of the 843 women interviewed, slightly less than half (43%, n = 361) thought that people living with HIV/AIDS should remain sexually active if they choose, while 13% (n = 113) said they thought that people living with HIV/AIDS should have children if they wished to do so. In multivariate analysis, negative attitudes towards both sexuality and childbearing were persistently associated with not knowing someone infected with HIV (p = 0.001 and 0.043, respectively). These findings suggest that the sexual and reproductive health rights of HIV-infected women and men may be an important target as part of efforts to reduce HIV/AIDS-related stigma. Health policies and services are required to reinforce the reproductive rights of HIV-infected individuals in South Africa and other countries in sub-Saharan Africa where HIV is most prevalent.

Impact of measurement error in the study of sexually transmitted infections.

Measurement is a fundamental part of all scientific research, and the introduction of errors of different sorts is an inevitable part of the measurement process in epidemiological and clinical research. Despite the ubiquity of measurement error in research, the substantial impacts which measurement error can have on data and subsequent study inferences are frequently overlooked. This review introduces the basic concepts of measurement error that are most relevant to the study of sexually transmitted infections, and demonstrates the impacts of several of the most common forms of measurement error on study results. A self assessment test and MCQs follow this paper.

A pilot study of a rapid assessment method to identify places for AIDS prevention in Cape Town, South Africa.

A multidisciplinary approach appears promising for focusing interventions. The PLACE method (priorities for local AIDS control efforts) identifies where prevention programmes can access sexual networks containing individuals with high rates of new partner acquisition and provides information about whether sexually transmitted disease (STD) or AIDS prevention programmes are in place at those sites. The method provides useful information at relatively low cost, regardless of the phase of the HIV or STD epidemic. For example, in the growth phase of an epidemic, information on where people with high rates of new partner acquisition meet new sexual partners could be used to inform targeted surveillance or screening programmes to catch early cases.

Informed choice--the timing of postpartum contraceptive initiation.

BACKGROUND: In South Africa injectable progestogen-only contraceptives (IPC) are typically administered to women immediately after delivery. Several guidelines advise that breast-feeding women should not commence IPC until 6 weeks postpartum on the basis of theoretical risks to the infant. OBJECTIVE: We examined women's preferences regarding timing of postpartum IPC initiation, as well as women's contraceptive and breast-feeding behaviours and pregnancy risk in the early postpartum period. DESIGN AND DATA COLLECTION: A cross-sectional study was conducted among 200 antenatal clinic (ANC) attendees and 180 mothers attending a child health clinic (CHC). At the ANC, women were given information on the theoretical risks of IPC and re-interviewed about their postpartum contraceptive intentions. RESULTS: Most ANC women planned to use IPCs (92%) and to breast-feed (98%) after delivery. Most CHC mothers had used IPCs (91%) and had breast-fed (83%) after delivery. When women at the ANC were provided with appropriate information they made decisions about when to initiate IPC by balancing the theoretical risks of IPC to their infant against their personal risk of pregnancy and ability to return to a clinic in the early postpartum period. CONCLUSION: It is important to include informed choice in postpartum IPC initiation guidelines.