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Cochrane Database of Systematic Reviews Protocol - Intervention

Home‐based HIV voluntary counseling and testing in developing countries

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

(1) To identify and critically appraise studies addressing the implementation of home‐based HIV voluntary counselling and testing in developing countries
(2) To determine whether home‐based HIV voluntary counselling and testing (HBVCT) is associated with improvement in HIV testing outcomes, compared to facility based models

Background

Acquired Immunodeficiency Syndrome (AIDS), a collection of signs and symptoms signifying immune deficiency, is caused by the Human Immunodeficiency Virus (HIV), a human retrovirus (Gallo 2003). It is estimated that 38 million people worldwide are infected with HIV, with over 90% in developing countries and 64% in sub‐Saharan Africa alone (24.5 million) (UNAIDS 2006). HIV is undoubtedly a major public health problem in developing countries. Early detection of the disease and timely access to care can improve the course of the disease and potentially reduce the rate of transmission. This review is intended to evaluate home‐based HIV testing as a model of testing that will lead to significantly higher uptake in resource‐limited settings.

The diagnosis of HIV depends on the provision of testing to both symptomatic and asymptomatic individuals in the community. HIV voluntary counselling and testing (VCT) is the first step in introducing people to effective HIV/AIDS care and is a central point in HIV prevention in developing countries (De Zoysa 1995; Summers 2000) and developed countries (Kaiser 2005). This intervention is vital in developing countries and in remote areas where the delivery of health services is fragmented and laboratory facilities are limited. By definition, VCT typically consists of a pre‐test counselling session with a trained counsellor and an HIV antibody test, followed by a post‐test session in which individuals are counselled on risk behaviours to ensure they remain uninfected (if tested negative) or avoid infecting others (if positive). Subjects testing positive are also provided with emotional support and referred to other treatment programmes. The target groups for VCT are usually individuals at high risk of HIV infection; however, in countries with generalized epidemics, the entire population is at risk. The primary aim of VCT programmes is helping people to know their HIV status and undergo risk‐reduction counselling in order to protect themselves and their partners against HIV infection (if uninfected) or be referred for care and treatment (if HIV‐infected).

Models of VCT
There are several different models of VCT, which are outlined in the following paragraphs.

Free‐standing services
This model offers VCT away from health services, but includes frequent referrals of patients to care and support services. These services have the advantage of dedicated staff, flexible hours of operation, and strong community links. However, staff burnout may limit available services and stigma may limit attendance.

Integrated VCT
These services are usually integrated into existing healthcare settings, such as sexually transmitted infection clinics (STIs), tuberculosis clinics, family planning, and mother‐and‐child health (MCH) services. Advantages include the ease of cross referrals and relatively low operating costs. However, they may not appeal to certain groups, such as young people or men who do not normally go readily to health facilities. Also, in the face of competing interests, staff may not be fully committed to the VCT program.

Mobile or community outreaches;
This is often a van or a similar mobile vehicle that is used for "hard‐to‐reach" populations. Such vehicles improve access, may be anonymous, and can link to other services. However, mobile VCT services can be expensive and not cost‐effective; they require many resources (both equipment and manpower); and can have difficulty ensuring follow‐up after post‐test counselling. Additionally, extensive community mobilization is required to ensure uptake on the service date. It may be challenging to ensure quality at temporary sites while simultaneously dealing with clients who have other pressing health needs.

Figure 1(De Cock 2006)
Over the last few years, several countries have innovated other ways of getting more people tested, and among them are the door‐to‐door services.


Traveling HIV Tester and Counselor (De Cock 2006)

Traveling HIV Tester and Counselor (De Cock 2006)

Home‐based VCT (HBVCT)
HBVCT involves door‐to‐door services that offer VCT in people's homes. They often involve the use of lay counsellors or community health workers to provide counselling and testing. Home‐based counsellors and testers move from home to home, provide pre‐test counselling (usually to the entire family) and obtain consent from eligible family members. Each family member is then tested and given post‐test counselling. Home‐based VCT addresses the needs of the entire family at once, and the resulting discussion on prevention and behaviour change may be more effective in the context of the family and the home. Other advantages include reduced perceived stigma, potentially cheaper operating costs (especially if community lay workers are utilized), and the possibility that couples counselling and disclosure may be easier, especially among discordant couples. However, HBVCT can be time‐consuming, as the provider must move from home to home, and family disclosure, especially of parents to children, may be difficult, as the parent(s) have to deal with knowledge of their status first. Testing everyone at the same time may mean premature disclosure, which may lead to adverse social outcomes.

Figure 2 (TASO 2005)
Figure 3 (TASO 2005)

Routine (or opt‐out) counselling and testing (RCT)
In this model, the HIV test is offered as part of routine medical care, usually with other tests that are requested during the patient's clinical visit. Counselling is offered in terms of groups and more emphasis is place on post‐test counselling. Patients who refuse the test are considered to have opted out. This model has been implemented in many countries in prevention of mother‐to‐child transmission (PMTCT), tuberculosis, STI clinics, and medical wards (Alcorn 2006) and has been recently recommended by the US Centers for Disease Control and Prevention (CDC) as one of the ways of increasing early diagnosis (CDC 2006). An advantage of this service is reduced start‐up costs, but it has been criticized for taking away the "voluntariness" from HIV testing.

Mandatory HIV testing
Mandatory HIV testing, on the other hand, involves performing an HIV test without getting consent from the individuals being tested. It was proposed as a way to address HIV among specific populations (such as pregnant women), with the aim of preventing HIV transmission to unborn children. However, when compared to VCT, the benefits do not outweigh the potential harms (Nakchbandi 1998). This method has also been suggested for sexual offenders and military recruits. Because of human rights issues, this method is not favoured as a public health intervention, as it may cause people to avoid seeking healthcare in order to avoid being tested.

VCT coverage and implementation of different models in resource‐limited settings
Regrettably, although VCT is an effective prevention intervention in resource‐constrained countries (VCT Efficacy 2000), coverage in many developing countries remains low for various reasons (Coovadia 2000; Prabhat 2002). Among the reasons: HIV‐related stigma and the distance involved in travelling to reach testing sites (including a return visit for post‐test counselling, especially in places where rapid testing is not performed) (Morrin 2006). For example, a national study in Uganda showed that 70% of adults reported wanting to receive testing, but only 6% had actually been tested (UBOS 2001). Similarly, about 50% of people hospitalized in Uganda are HIV‐infected, but HIV testing is rarely available in hospitals and almost never routinely offered to patients (Wanyenze 2004). Notably, before rapid testing became more widely available, those who were tested in hospitals and other facilities were less likely to return for their results (Fylkesnes 1999; Wolff 2005).


A housewife undergoing HIV testing in the comfort of her home

A housewife undergoing HIV testing in the comfort of her home


TASO Jinja counselor and tester performing HIV rapid test in the home and taking a dry blood spot for quality control

TASO Jinja counselor and tester performing HIV rapid test in the home and taking a dry blood spot for quality control

Making rapid HIV testing more widely available and accessible could have a significant impact on the prevention of HIV infection in developing countries. Analysis of an intervention to deliver HIV test results to people's homes in a rural cohort in South Western Uganda showed an increase in the uptake of results from 10% to 37% (Wolff 2005). Likewise, following the implementation of home‐based VCT by the AIDS Information Centre (AIC), Uganda's pioneer testing site, 5000 people received VCT in 2000 homes over a one‐year period. In over 65% of the homes, at least one family member agreed to participate in testing (Murana 2005). A study cohort in Rakai district in South Western Uganda also showed a rise in uptake of VCT, from 35% in the first year (1994 to 1995) to 65% subsequently (1999 to 2000) (Matovu 2002), while one‐time delivery of HIV results after community‐wide mobilization in Mukono (a rural Ugandan district), yielded an uptake of 93% (Were 2003). In Zimbabwe, inconvenience of location and hours of testing were the main reasons given for the lack of previous testing in a group of people accessing VCT at a mobile testing site (Morrin 2006).

In a bid to scale up VCT, Lesotho, a country with one of the highest HIV prevalences in the world, has embarked on a nationwide home‐based HIV voluntary testing program (WHO 2005). It is expected that all households will be offered HIV tests through door‐to‐door VCT services by the end of 2007. This programme is expected to have a significant impact in providing care and helping to implement changes in sexual behaviour (WHO 2005).

Most of these programmes have targeted household members of persons living with HIV infection to initiate prevention services for those who are not HIV‐infected, and care interventions for those who have undiagnosed HIV infection. For example, a program in Eastern Uganda identified previously undiagnosed HIV infection in 25% of adult family members and 10% of the children of the index clients recruited into an antiretroviral project (Were 2003; Mermin 2005). In the same location, 74% of new HIV infections among the 176 HIV‐infected family members tested had never been tested before (Were 2006). VCT programs have the potential to encourage disclosure of HIV status, reduce depression and anxiety, enhance family adherence support, and increase risk reduction within HIV‐discordant couples.

Gaps and challenges
Although results from a randomized multi‐centre controlled trial in Kenya, Tanzania, and Trinidad have demonstrated that VCT is an effective intervention in resource‐constrained countries (VCT Efficacy 2000), VCT coverage in many developing countries remains low. The benefits of introducing home‐based testing are significant in several settings. Testing other family members specifically increases family diagnosis of HIV infection, and targeting older siblings of HIV‐exposed children is an important way of reducing paediatric mortality. The testing of the older siblings of HIV‐exposed infants has been implemented in Guyana with encouraging results (Guyana 2005). It is, however, a challenge to get families to come to clinics for testing. In countries where significant challenges exist to testing at clinic sites, home‐based testing may provide an opportunity to increase programme success and improve HIV prevention efforts. It also creates an awareness and could be an entry point to home‐based care (Were 2006).

Many studies have assessed the uptake of VCT in different situations (facility‐based, standalone) and, more recently, in home‐based VCT. However, no primary analyses have been conducted to evaluate which method is most appropriate and effective for developing countries. Currently, one systematic review is underway to examine the effectiveness of counselling and testing for preventing HIV infection (Sweat 1998). However, this review is not explicit to home‐based HIV testing. The current review will assess the effectiveness of home‐based HIV voluntary counselling and testing to improve access to HIV care and prevention in developing countries. This review is vital in order to establish the best delivery method of VCT, given the low uptake of facility‐based testing models and the urgency of addressing the HIV epidemic in developing countries, where the majority of HIV/AIDS patients reside and are in dire need of care and treatment.

While randomized controlled trials would present the best evidence for the effectiveness and benefits of home‐based HIV counselling and testing, due to the difficulty of designing RCTs, data from observational studies will be included in this review in order to provide additional evidence.

Objectives

(1) To identify and critically appraise studies addressing the implementation of home‐based HIV voluntary counselling and testing in developing countries
(2) To determine whether home‐based HIV voluntary counselling and testing (HBVCT) is associated with improvement in HIV testing outcomes, compared to facility based models

Methods

Criteria for considering studies for this review

Types of studies

Randomized trials comparing home‐based HIV VCT against other models of VCT (such as facility‐based models) will be included. However, in addition to RCTs, identified non‐randomized trials (e.g. cohort and observational studies) that evaluate home‐based testing against other models will be considered for inclusion. Additional pre‐ and post‐test studies comparing home‐based HIV testing against other rapid HIV testing models in different settings will also be included. Both published and unpublished studies will be considered. Ongoing primary studies will be excluded from the review, but will be listed in the table of ongoing studies.

Types of participants

Adult subjects aged 18 years or older who are either HIV‐negative or unaware of their HIV status, and have been screened for HIV infection, will be eligible for inclusion after having given informed consent. Only studies done in developing countries will be included.

Types of interventions

Home‐based testing refers to provision of HIV voluntary counselling and testing in the home setting or household. This includes any home‐based HIV rapid testing used as a screening tool for HIV infection and with the following features:

  • provision of pre‐test counselling in the home;

  • performance of HIV rapid testing at home;

  • provision of HIV test results and post‐test counselling in the home; and

  • referral of study of study participants with HIV‐positive test results for care.

Control (comparison)
HIV testing outside the home environment in other settings, including hospitals, standalone VCT sites, health centres, mobile clinics, etc.

Types of outcome measures

Primary
The included studies must have one of the following outcome measures:

  • HIV test pre‐test counselling accepted;

  • HIV test results accepted;

  • HIV infection diagnosed based on positive rapid tests; or

  • post‐test counselling accepted.

Secondary

  • Mean score on subject‐satisfaction level with quality of VCT received.

Search methods for identification of studies

We will identify all relevant studies, regardless of language or publication status (published, unpublished, in‐press, and in‐press and ongoing). The following broad terms will be used in the search; HIV, "Voluntary counselling and testing," "developing countries," and "home‐based."

Databases
We will search the following databases using the search terms mentioned above and specified for each database:

i. The Cochrane HIV Group's Trials Register
ii. The Cochrane Central Register of Controlled Trials (CENTRAL). Published in The Cochrane Library (Issue 3, 2006) All articles with * HIV voluntary counselling and testing*
iii. MEDLINE (1980 to September 2006) will be searched using the following search strategy:
1. "HIV"[MeSH Terms] OR HIV
2. "HIV testing" [MeSH Terms]
3. home‐based OR home based OR door‐to‐door OR door to door
4. "home care services" [MeSH Terms]
5. voluntary
6. randomised
7. #1 OR #2
8. #3 OR #4 OR #5
9. #6 AND #7 AND #8 {combining all terms)

iv. EMBASE online will be searched from 1980‐2006
v. CINAHL
vi. Sociofile
vii. LILACS

Conference proceedings
i. Conference abstract books (International AIDS Society)
ii. International (International AIDS Conferences I‐XVI), regional (International Conference on AIDS and Sexually Transmitted Infections in Africa I‐XIV), and national conference proceedings/reports and will identify unpublished reports of relevance to the review.
The AIDSLINE will be searched from 1980‐2006 using the following strategy:
#1 HIV
#2 TESTING
#3 HOME‐BASED
#4 VOLUNTARY

Researchers, organizations and pharmaceutical companies
Where required, sponsors and authors working on home‐based testing, pharmaceutical companies and non‐governmental organizations implementing HIV testing in developing countries will be contacted to identify more unpublished reports and ongoing studies.

Reference lists
Handsearching will be conducted for secondary references of all studies identified by the above methods, as well as reviews and HIV prevention guidelines. We will also check all references from systematic reviews, meta‐analyses and treatment guidelines that we identify.

Data collection and analysis

All titles and abstracts identified by the electronic and manual searches will be read by MB and OA to screen for relevant material, identify citations, and match against the inclusion criteria.

Selection of studies
All article abstracts identified by the search will be independently screened by MB and OA, and any differences resolved by SMK in consultation with editors of The Cochrane HIV/AIDS Group. We will obtain the full text of potentially relevant studies and assess them for inclusion, using pre‐designed eligibility forms based on the inclusion criteria above. We will discuss the reasons for excluding potentially relevant studies and tabulate them in the 'Characteristics of excluded studies.'

Data extraction
Both authors will independently extract data from the included studies, using pre‐developed data extraction forms. Two different extraction forms will be used. One will be for RCTs (if identified), and the second for cohort or cross‐sectional studies. For continuous variable, we will extract the number of subjects per group and the mean (and standard deviation) within the group. For dichotomous outcomes, we will abstract the number of per‐group participants and the number experiencing the outcome. Disagreements between the reviewer authors will be resolved by consensus and by the third review author (SMK). In the event of missing data, we will endeavour to contact the authors of the included studies for clarification and additional information. Where we require unpublished data, we will also contact the trial authors for further information

Data analysis
RevMan 4.2 software will be used to enter and analyze the data (RevMan 2003) and obtain summary statistics for the four dichotomous outcomes of interest listed above. When possible we will combine the results of included studies in a meta‐analysis stratified by type of study: RCTs and cohort/observational studies. We will report the relative risks and 95% confidence intervals. We will use both fixed and random‐effect models if studies are sufficiently clinically, methodologically, and statistically similar. If there is statistical heterogeneity (I² test), we will explore the possible causes, such as study site (rural versus urban). Where trials are considered too dissimilar to combine in meta‐analyses, results will be tabulated and summarised. We will evaluate heterogeneity by visual scrutiny of tabulated outcomes and by deriving two measures of heterogeneity (Chi Square, p‐value [<0.1] and I² statistics). We will do selective removal of individual outlying studies to examine the influence this will have on heterogeneity. We will use funnel plots to examine publication bias.

Subgroup analysis
Two main subgroup analyses will be performed. The first will involve RCTs (if any) and the second will involve observational data. We will also stratify observational studies by study design (cohort versus cross‐sectional), since the primary outcome measures are likely to be influenced by different HIV test strategies. For example, studies in urban areas may differ from those in rural areas, and studies in specific groups, such as those evaluating VCT uptake in pregnant women, may affect the primary outcomes differently.

Traveling HIV Tester and Counselor (De Cock 2006)
Figures and Tables -
Figure 1

Traveling HIV Tester and Counselor (De Cock 2006)

A housewife undergoing HIV testing in the comfort of her home
Figures and Tables -
Figure 2

A housewife undergoing HIV testing in the comfort of her home

TASO Jinja counselor and tester performing HIV rapid test in the home and taking a dry blood spot for quality control
Figures and Tables -
Figure 3

TASO Jinja counselor and tester performing HIV rapid test in the home and taking a dry blood spot for quality control