HIV This Week

Mfinanga GS, Mutayoba B, Mbogo G, Kahwa A, Kimaro G, Mhame PP, Mwangi C, Malecela MN, Kitua AY. Quality of HIV laboratory testing in Tanzania: a situation analysis. Tanzan Health Res Bull. 2007 Jan;9(1):44-7.

Tanzania is scaling up prevention, treatment, care and support of individuals affected with HIV. There is therefore a need for high quality and reliable HIV infection testing and AIDS staging. The objective of this study was to assess laboratories capacities of services in terms of HIV testing and quality control. A baseline survey was conducted from December 2004 to February 2005 in 12 laboratories which were conveniently selected to represent all the zones of Tanzania. The questionnaires comprised of questions on laboratory particulars, internal and external quality control for HIV testing and quality control of reagents. Source and level of customer satisfaction of HIV test kits supply was established. Of 12 laboratories, nine used rapid tests for screening and two used rapid tests for diagnosis. In the 12 laboratories, four used double ELISA and five used single ELISA and three did not use ELISA. Confirmatory tests observed were Western Blot in three laboratories, DNA PCR in two laboratories, CD4 counting in seven laboratories, and viral load in two laboratories. Although all laboratories conducted quality control (QC) of the HIV kits, only two laboratories had Standard Operating Procedures (SOPs). Internal and external quality control (EQC) was done at varied proportions with the highest frequency of 55.6% (5/9) for internal quality control (IQC) for rapid tests and EQC for ELISA, and the lowest frequency of 14.3% (1/ 7) for IQC for CD4 counting. None of the nine laboratories which conducted QC for reagents used for rapid tests and none of the five which performed IQC and EQC had SOPs. HIV kits were mainly procured by the Medical Store Department and most of laboratories were not satisfied with the delay in procurement procedures. Most of the laboratories used rapid tests only, while some used both rapid tests and ELISA method for HIV testing. In conclusion, the survey revealed inadequacy in Good Laboratory Practice and poor laboratory quality control process for HIV testing reagents, internal and external quality control.

Editors’ note: The case of a man whose marriage plans were annulled as a result of a false positive HIV test result underscores the importance of observing Good Laboratory Practice and instituting quality control procedures. This type of situation analysis needs to be conducted in all countries.

---

Bell E, Mthembu P, O'sullivan S; on behalf of the International Community of Women Living with HIV/AIDS, Moody K; on behalf of the Global Network of People with HIV/AIDS. Sexual and reproductive health services and HIV testing: perspectives and experiences of women and men living with HIV and AIDS. Reprod Health Matters 2007;15:113-35.

All over the world HIV has been stigmatised, making it difficult for people living with HIV to access testing, treatment, care and counselling or even to act on a diagnosis or get advice and treatment, for fear of being judged. Prejudice in society has also often been reflected and reproduced by health care providers. A human rights approach, which positively incorporates sexual and reproductive rights, rather than a restricted medical view, is therefore essential for the achievement of true partnerships between health care providers and service users. This paper is about the experiences of HIV positive women and men in sexual and reproductive health services and HIV testing. It provides guidance not only on how things could and should be done but also on how they should not be done. It outlines the sexual and reproductive rights positive people consider crucial and gives examples of how these are being violated. It presents perceptions and implications of HIV testing and how health services can support people after a positive diagnosis. It analyses the importance of confidentiality, continuity of care, knowledge and information, and the role of support groups and home-based care. It calls on sexual and reproductive health services to address issues of stigma and discrimination when offering and carrying out HIV testing and counselling, and in providing treatment, care and support.

Editors’ note: This paper highlights perspectives of people living with HIV which can help guide best practices in HIV testing, treatment, care and support. Stigma is a huge barrier to care, treatment, and support worldwide, and addressing this barrier will allow improved access, not merely improved offering or availability, of care, treatment, and support.

---

Lee VJ, Tan SC, Earnest A, Seong PS, Tan HH, Leo YS. User acceptability and feasibility of self-testing with HIV rapid tests. J Acquir Immune Defic Syndr 2007;45:449-453.

Because HIV rapid tests are considered for self-testing, this study aims to determine the user acceptability and feasibility of self-testing. A cross-sectional study was performed on 350 systematically sampled participants across 2 Singapore HIV testing centers using the Abbott Determine HIV 1/2 blood sample rapid test (Abbott Laboratories, Abbott Park, IL). Participants were surveyed on knowledge of and attitudes toward rapid testing. To determine interrater agreement between self-testing and trained personnel testing, participants performed self-testing with visual instructions, followed by trained personnel testing. Ability to identify test outcomes was determined through interpretation of sample test results. Eighty-nine percent of participants preferred testing in private, but most indicated that confidential counselling by trained counsellors was necessary. Almost 90% found the kit easy to use and instructions easy to understand. Nevertheless, 85% failed to perform all steps correctly, especially blood sampling, and 56% had invalid results because of incorrect test performance. Interrater agreement between results from self-testing and trained personnel testing had a kappa value of 0.28. Twelve percent could not correctly determine results using sample tests, including 2% and 7% who read positive and negative samples, respectively, incorrectly. A substantial proportion could not perform self-testing or identify outcomes. Self-testing with the Determine HIV 1/2 kit in Singapore should be deferred.

Editors’ note: Although self-testing with rapid tests has the advantages of convenience and anonymity, high levels of inappropriate usage may cause more harm than good. In this study, most participants wanted the support of a trained counsellor which can reduce misunderstandings and alleviate stress/fear. Self-testing test performance will have to improve dramatically before it can be recommended.

---

Ou CY, Yang H, Balinandi S, Sawadogo S, Shanmugam V, Tih PM, Adje-Toure C, Tancho S, Ya LK, Bulterys M, Downing R, Nkengasong JN. Identification of HIV-1 infected infants and young children using real-time RT PCR and dried blood spots from Uganda and Cameroon. J Virol Methods. 2007 Jun 4; [Epub ahead of print]

Serodiagnosis of HIV infection in infants born to HIV-infected mothers is problematic due to the prolonged presence of maternal antibodies in infants. Nucleic acid-based amplification assays have been used to overcome this problem. Here a simplified, one-tube, real-time, duplex reverse transcription PCR (RT PCR) assay is shown to detect HIV-1 total nucleic acid (TNA) isolated from dried blood spots. The detection of TNA, as opposed to DNA alone, increases the HIV target molecules and thus makes the assay more robust. This method was used to detect HIV from the DBS collected from HIV-1 exposed infants and young children in Uganda (n=128) and Cameroon (n=315). The gold-standards used were a plasma viral assay in Uganda and Amplicor DNA assay in Cameroon. The concordance of this real-time assay and the gold standards was 99.2% (127/128) and 99.4% (313/315) with the Ugandan and Cameroonian samples, respectively. This simple and cost-effective assay is potentially useful for the diagnosis of paediatric HIV infection and for evaluating programs to reduce mother-to-child transmission of HIV-1.

Editors’ note: Early diagnosis of paediatric HIV infection permits tailored care with closer monitoring to determine eligibility for antiretroviral treatment, continuation of cotrimoxazole prophylaxis, and nutritional counselling.

Thuy TT, Shah NS, Anh MH, Nghia do T, Thom D, Linh T, Sy DN, Duong BD, Chau LT, Mai PT, Wells CD, Laserson KF, Varma JK. HIV-associated TB in An Giang Province, Vietnam, 2001-2004: epidemiology and TB treatment outcomes. PLoS ONE 2007;62:e507.

Mortality is high in HIV-infected tuberculosis (TB) patients, but few studies from Southeast Asia have documented the benefits of interventions, such as co-trimoxazole (CTX), in reducing mortality during TB treatment. To help guide policy in Vietnam, Thuy and colleagues studied the epidemiology of HIV-associated TB in one province and examined factors associated with outcomes, including the impact of CTX use. The authors retrospectively abstracted data for all HIV-infected persons diagnosed with TB from 2001-2004 in An Giang, a province in southern Vietnam in which TB patients receive HIV counselling and testing. The authors used standard WHO definitions to classify TB treatment outcomes. They conducted multivariate analysis to identify risk factors for the composite outcome of death, default, or treatment failure during TB treatment. From 2001-2004, 637 HIV-infected TB patients were diagnosed in An Giang. Of these, 501 (79%) were male, 321 (50%) were aged 25-34 years, and the most common self-reported HIV risk factor was sex with a commercial sex worker in 221 (35%). TB was classified as smear-positive in 531 (83%). During TB treatment, 167 (26%) patients died, 9 (1%) defaulted, and 6 (1%) failed treatment. Of 454 patients who took co-trimoxazole (CTX), 116 (26%) had an unsuccessful outcome compared with 33 (70%) of 47 patients who did not take CTX (relative risk, 0.4; 95% confidence interval [CI], 0.3-0.5). Adjusting for male sex, rural residence, TB smear status and disease location, and the occurrence of adverse events during TB treatment in multivariate analysis, the benefit of CTX persisted (adjusted odds ratio for unsuccessful outcome 0.1; CI, 0.1-0.3). In An Giang, Vietnam, HIV-associated TB was associated with poor TB treatment outcomes. Outcomes were significantly better in those taking CTX. This finding suggests that Vietnam should consider applying WHO recommendations to prescribe CTX to all HIV-infected TB patients.

Editors’ note: Patients co-infected with TB and HIV are at high risk of death not only because of TB but also due to increased susceptibility to pneumonia and other infections. These data from southern Vietnam reinforce the benefits of co-trimoxazole – it should be offered to all adults with TB at the onset of anti-TB treatment as an effective, simple, and safe way to reduce mortality, especially in settings where HIV co-infection is common.

Delvaux T, Nöstlinger C. Reproductive Choice for Women and Men Living with HIV: Contraception, Abortion and Fertility. Reprod Health Matters. 2007 May;15(29 Suppl):46-66.

From a policy and programmatic point of view, this paper reviews the literature on the fertility-related needs of women and men living with HIV and how the entry points represented by family planning, sexually transmitted infection and HIV-related services can ensure access to contraception, abortion and fertility services for women and men living with HIV. Most contraceptive methods are safe and effective for HIV positive women and men. The existing range of contraceptive options should be available to people living with HIV, along with more information about and access to emergency contraception. Potential drug interactions must be considered between hormonal contraception and treatment for tuberculosis and certain antiretroviral drugs. Couples living with HIV who wish to use a permanent contraceptive method should have access to female sterilisation and vasectomy in an informed manner, free of coercion. How to promote condoms and dual protection and how to make them acceptable in long term-relationships remains a challenge. Both surgical and medical abortion are safe for women living with HIV. To reduce risk of vertical transmission of HIV and in cases of infertility, people with HIV should have access to sperm washing and other assisted conception methods, if these are available. Simple and cost-effective procedures to reduce risk of vertical transmission should be part of counselling for women and men living with HIV who intend to have children. Support for the reproductive rights of people with HIV is a priority. More operations research on best practices is needed.

Editors’ note: Sperm washing is expensive and not widely available. There are anecdotal reports of couples who want children minimising the risk of HIV transmission by having the HIV-negative woman take short course triple therapy as prophylaxis during unprotected sex with her HIV-positive male partner who has undetectable viral load levels. This makes theoretical sense even if success rates have not been documented.

---

Kidder DP, Wolitski RJ, Royal S, Aidala A, Courtenay-Quirk C, Holtgrave DR, Harre D, Sumartojo E, Stall R; Access to Housing as a Structural Intervention for Homeless and Unstably Housed People Living with HIV: Rationale, Methods, and Implementation of the Housing and Health Study. AIDS Behav.2007 Jun 2; [Epub ahead of print].

Homelessness and unstable housing have been associated with HIV risk behaviour and poorer health among persons living with HIV (PLHIV), yet prior research has not tested causal associations. This paper describes the challenges, methods, and baseline sample of the Housing and Health Study, a longitudinal, multi-site, randomized controlled trial investigating the effects of providing immediate rental housing assistance to PLHIV who were homeless or at severe risk of homelessness. Primary outcomes included HIV disease progression, medical care access and utilization, treatment adherence, mental and physical health, and risks of transmitting HIV. Across three study sites, 630 participants completed baseline sessions and were randomized to receive either immediate rental housing assistance (treatment group) or assistance finding housing according to local standard practice (comparison group). Baseline sessions included a questionnaire, a two-session HIV risk-reduction counselling intervention, and blood sample collection to measure CD4 counts and viral load levels. Three follow-up visits occurred at 6, 12, and 18 months after baseline. Participants were mostly male, Black, unmarried, low-income, and nearly half were between 40 and 49 years old. At 18 months, 84% of the baseline sample was retained. The retention rates demonstrate the feasibility of conducting scientifically rigorous housing research, and the baseline results provide important information regarding characteristics of this understudied population that can inform future HIV prevention and treatment efforts.

Editors’ note: Whether addressing access to housing concerns among this population of people living with HIV more expeditiously will have positive effects on their risk behaviour and health status remains to be seen – unfortunately the sample size may be too small to detect differences over an 18 month period.

---

Segurado AC, Paiva V. Rights of HIV Positive People to Sexual and Reproductive Health: Parenthood. Department of Infectious Diseases, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Reprod Health Matters. 2007 May;15(29 Suppl):27-45.

In many areas of the globe most HIV infection is transmitted sexually or in association with pregnancy, childbirth and breastfeeding, raising the need for sexual and reproductive health and AIDS initiatives to be mutually reinforcing. Many people with HIV, who are in good health, will want to have children, and highly active antiretroviral therapy provides women and men living with AIDS the possibility of envisaging new life projects such as parenthood, because of a return to health. However, there are still difficult choices to face concerning sexuality, parenthood desires and family life. Structural, social and cultural issues, as well as the lack of programmatic support, hinder the fulfilment of the right to quality sexual and reproductive health care and support for having a family. This paper addresses the continuum of care involved in parenthood for people living with HIV, from pregnancy to infant and child care, and provides evidence-based examples of policies and programmes that integrate sexual and reproductive health interventions with HIV-related care in order to support parenthood. Focusing on parenthood for people living with and affected by HIV, that is, focusing on the couple rather than the woman as the unit of care, the individual or the set of adults who are responsible for raising children, would be an innovative programmatic advance. Going beyond maternal and child health care to providing care and support for parents and others who are responsible for raising children is especially relevant for those living with HIV infection.

Editors’ note: In some settings the term ‘parent-to child transmission’ is gaining currency as the focus is increasingly on the couple and the parenting choices and capacities of both parents.

Orrell C, Harling G, Lawn SD, Kaplan R, McNally M, Bekker LG, Wood R. Conservation of first-line antiretroviral treatment regimen where therapeutic options are limited. Antivir. Ther. (Lond.). 2007;12(1):83-8

Orrelle et al aimed to determine rates and causes of switching from first- to second-line antiretroviral treatment (ART) regimens in a large treatment-naive cohort (a South African community-based ART service) where a targeted adherence intervention was used to manage initial virological breakthrough. They studied ART-naive adults (n=929) prospectively who were commencing first-line non-nucleoside-based ART [according to WHO (2002) guidelines] between September 2002 and August 2005. Viral load (VL) and CD4+ T-cell counts were monitored every 4 months. All drug switches were recorded. Counsellor-driven adherence interventions were targeted to patients with a VL > 1000 copies/ml at any visit (virological breakthrough) and the VL measurement was repeated within 8 weeks. Two consecutive VL measurements > 1000 copies/ml was considered virological failure, triggering change to a second-line regimen. During 760 person-years of observation [median (IQR) 189 (85-441) days], 823 (89%) patients were retained on ART, 2% transferred elsewhere, 7% died and 3% were lost to follow-up. A total of 893 (96%) patients remained on first-line therapy and 16 (1.7%) switched to second-line due to hypersensitivity reactions (n=9) or lactic acidosis (n=7). A Kaplan-Meier estimate for switching to second-line due to toxicity was 3.0% at 32 months. Virological breakthrough occurred in 67 (7.2%) patients, but, following use of a targeted adherence intervention, virological failure was confirmed in just 20 (2.2%). Kaplan-Meier estimates at 32 months were 20% for virological breakthrough but only 5.6% for confirmed virological failure. Overall the authors found that regimen switches were due to virological failure or toxicity. Although follow-up time was limited, over 95% of individuals remained on first-line ART using a combination of viral monitoring and a targeted adherence intervention.

Editors’ note: This study highlights the importance of close monitoring of CD4 counts and viral load to conserve the effectiveness of first line regimens by heading off virological failure through targeted adherence support.