Opt-out provider-initiated HIV testing and counseling in primary care outpatient clinics in Zambia


Topp SM, Chipukuma JM, Chiko MM, Wamulume CS, Bolton-Moore C, Reid SE


Bull World Health Organ 2011; 89:328-355A


The World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the United States Centers for Disease Control and Prevention (CDC) recommend provider-initiated testing and counselling (PITC) as a cost-effective and ethical way of improving access to HIV testing during general epidemics. Nevertheless, client-initiated, or opt-in, voluntary counselling and testing (VCT) remains the dominant form of testing in many sub-Saharan African countries, including Zambia.While VCT has been effective in identifying substantial numbers of HIV-positive (HIV+) individuals, in 2007 it was estimated that as many as 80% of HIV-infected adults in sub-Saharan Africa were unaware of their HIV serostatus and only 2.2% of all adults were tested annually. The introduction of routine opt-out PITC would offer an additional point of entry to HIV care and treatment for affected individuals.

In routine opt-out PITC, HIV testing and counselling are recommended as standard components of medical care at health-care facilities.The term “opt-out” means that patients must explicitly refuse an HIV test. Routine opt-out PITC encourages a streamlined approach to HIV testing that involves simplified pretest counselling and verbal rather than written consent. Despite lingering ethical concerns about patients feeling coerced into being tested, there is a burgeoning body of evidence suggesting that routine opt-out PITC can play an important part in scaling up access to HIV testing, care and treatment in places where infection is highly prevalent.

This paper describes findings obtained during the first 30 months of a programme designed to introduce PITC for HIV infection into the outpatient departments of nine primary health-care clinics in Lusaka, Zambia, as part of an initiative to integrate primary care for patients with and without HIV infection. The programme had two primary objectives: (i) to improve uptake of HIV testing by offering an accessible and acceptable alternative to VCT and (ii) to improve HIV case-finding among patients attending outpatient departments who may be independently seeking outpatient medical care but not HIV care and treatment.



In April 2004, a large-scale public sector HIV care and treatment programme was established in Lusaka by the Zambian Ministry of Health with implementation assistance from the Centre for Infectious Disease Research in Zambia (CIDRZ) and funding from the President’s Emergency Plan for AIDS Relief (PEPFAR). Details of the Lusaka programme have been described previously.

Between July 2008 and June 2010, an integrated approach to outpatient care for individuals with and without HIV infection was introduced in a staggered fashion into nine urban primary health-care clinics in Lusaka. Clinical and administrative services at each clinic were harmonized for patients with and without HIV infection in three key ways: (i) the physical space used by patients and patient flows were amalgamated; (ii) medical records were standardized and (iii) routine PITC was introduced. All patients attending outpatient departments were referred for pretest counselling under the PITC programme unless they were already receiving HIV care and treatment or had evidence of being tested for HIV within the last 6 months (e.g. the test was reported in medical records or a test slip was available from a recognized external test provider).

Counselling and testing at each clinic were provided by two lay counsellors who were trained in psychosocial and provider-initiated counselling techniques. They worked in 5-hour shifts. Counselling was carried out in accordance with WHO and Zambian national guidelines and the presence of HIV was initially detected using the rapid Determine HIV-1/2 test (Abbott Laboratories, Abbott Park, United States of America). Positive HIV test results were confirmed using the Uni-Gold HIV test (Trinity Biotech, Bray, Ireland) and any conflicting results were resolved using the Bioline test (Standard Diagnostics Incorporated, Suwon City, Republic of Korea). Patients underwent pretest counselling either individually or in groups. However, they were always seen in private when deciding whether to opt in or out of HIV testing, while undergoing testing and during post-test counselling. Patients who opted out continued to follow normal outpatient procedures. Those who opted in proceeded to testing and underwent post-test counselling, regardless of the test result. Patients found to be HIV+ could enrol in the HIV care and treatment programme immediately or on a predetermined date.

Lay counsellors were supervised by the individuals in charge of the health centres and received group mentoring at quarterly review meetings facilitated by a CIDRZ nurse. Lay counsellors at the five clinics first involved in the integrated primary care programme and the introduction of PITC were hired on yearly renewable contracts by the Lusaka District Health Management Team using funds from PEPFAR. Donor funding for these positions was being maintained in early 2011 but it was expected that counsellors would be transferred permanently onto the Zambian Ministry of Health payroll. Lay counsellors at clinics subsequently involved in the PITC programme were trained and hired by the Ministry of Health. Clinics that provided VCT continued to do so after the introduction of PITC. Community awareness programmes, which involved drama performances and door-to-door visits by neighbourhood health committees, took place in clinic catchment areas 4–6 weeks before and after the implementation of PITC and provided information about the integration of care for patients with and without HIV infection and the introduction of PITC.

Data collection and analysis

Registers kept in counselling rooms were used to record patients’ personal details, including gender and age, whether HIV testing was accepted or refused and, where appropriate, the reason for refusal. For patients who accepted, details of the test result, the date it was received and, for those who were HIV+, the date of enrolment in the HIV care and treatment programme were also recorded. The registers were reviewed each month by the individuals in charge of the clinics to evaluate how systems were functioning, to gauge counsellors’ performances and to ensure that orders for test kits and reagents were accurate. The registers were stored in a locked drawer in a locked room when not in use.

For this study, anonymous data on the number of patients counselled, tested and found to be HIV+ were collated monthly and entered manually into an electronic database. Data were checked for accuracy and completeness by the CIDRZ project coordinator. Details of patients who tested HIV+ during PITC were cross-referenced with entries on the national SmartCare electronic medical database to track those who enrolled in HIV care and treatment. Operational constraints prevented patients’ records being harmonized at two clinics, which meant that patients who tested HIV+ during PITC could not be tracked to determine if they enrolled in HIV care and treatment. The rate of enrolment in the HIV care and treatment programme was calculated by dividing the total number of patients who enrolled at the seven clinics with harmonized patient records by the total number of patients who tested HIV+ at all nine clinics taking part in the PITC programme. Consequently, the enrolment rate was probably underestimated.

The time to enrolment in the HIV care and treatment programme was defined as the number of days between the date of the patient’s test recorded in the PITC register and the date of enrolment recorded in the patient’s SmartCare electronic record. Although both mean and median times to enrolment were calculated, the median was considered the better measure because there was a small number of extreme outliers. Data analyses were performed using Microsoft Excel 2007 (Microsoft, Redmond, USA). The study protocol was approved by the institutional review boards of the University of Zambia in Lusaka, Zambia, and the University of Alabama at Birmingham, United States of America.


Over 30 months, the staggered introduction of PITC at nine primary health-care clinics, as part of the programme to integrate care for patients with and without HIV infection, resulted in 44 420 patients receiving counselling. After subtracting patients who should not have undergone counselling because they knew and could prove their HIV status, the number counselled for the first time was 41 861. Of these patients, 31 197 (75%) agreed to be tested. Subsequently, 6572 (21% of those tested) were found to be HIV+ and 2515 (38% of HIV+ patients) enrolled in the HIV care and treatment programme. Overall, 44% of individuals who accepted testing were male, as were 41% of the HIV+ patients who enrolled in the care and treatment programme.

Over time, the percentage of individuals who accepted testing increased at all sites, as did the proportion who refused testing because their HIV status was known (Fig. 1). Fig. 1 shows that the overall rate of acceptance of HIV testing increased from 52% in the first 3 months of the programme (i.e. July to September 2008) to 83% in the last 3 months reported (i.e. October to December 2010). Full details of the number of patients who underwent counselling, accepted testing and were found to be HIV+ at the nine clinics in each month during the PITC programme are shown in Table 1 (available at: http://www.who.int/bulletin/volumes/89/5/10-084442). The clinics are numbered 1 to 9 according to the date of entry into the programme, such that Clinic 1 was involved first. The mean percentage of patients who accepted testing at individual clinics ranged from 47% in Clinic 9 to 99% in Clinic 8, while the mean percentage found to be HIV+ each month ranged from 13% to 26%. The rate of enrolment in the HIV care and treatment programme among HIV+ patients was low overall (38%), although it was higher in clinics with longer experience: Clinic 1: 47%; Clinic 2: 59%; Clinic 3: 50%; Clinic 4: 44%; Clinic 5: 43%; Clinic 8: 14% and Clinic 9: 25%. As noted earlier, patients in Clinics 6 and Clinic 7 could not be tracked from PITC to HIV care and treatment.

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