Malawi: Routine test offer at immunisation clinics improves early infant HIV diagnosis

This article is more than 12 years old. Click here for more recent articles on this topic

Integration of testing for early infant diagnosis was acceptable and feasible at a government immunisation clinic (IC); the proportion of infants who received provider-initiated testing and counselling (PITC) was seven times higher at this sort of clinic than for those attending a government 'under-five' clinic in Lilongwe, Malawi, researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

In this prospective consecutive study of 877 and 880 children at an under-five clinic and an immunisation clinic respectively, more than three times the proportion of HIV-exposed infants at the immunisation clinic returned for their polymerase chain reaction (PCR) results and then enrolled into care, compared to those attending the under-five clinic (78.6% compared to 25%, p<0.001).

Malawi has an HIV prevalence rate of 11%. In 2007, the government, wanting to improve infant HIV care, started using HIV-DNA PCR testing for early infant diagnosis.



Immunisation is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease.


polymerase chain reaction (PCR)

A method of amplifying fragments of genetic material so that they can be detected. Some viral load tests are based on this method.


In HIV, refers to the act of telling another person that you have HIV. Many people find this term stigmatising as it suggests information which is normally kept secret. The terms ‘telling’ or ‘sharing’ are more neutral.

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.


acute infection

The very first few weeks of infection, until the body has created antibodies against the infection. During acute HIV infection, HIV is highly infectious because the virus is multiplying at a very rapid rate. The symptoms of acute HIV infection can include fever, rash, chills, headache, fatigue, nausea, diarrhoea, sore throat, night sweats, appetite loss, mouth ulcers, swollen lymph nodes, muscle and joint aches – all of them symptoms of an acute inflammation (immune reaction).

The current early infant diagnosis programme recommends all HIV-infected mothers bring their infants at six weeks of age, whether well or not, for PCR testing and evaluation at an under-five clinic. Yet over half of these HIV-exposed infants are never enrolled into the early infant diagnosis process and do not get a PCR test. If they do get a PCR test it is only after they become ill, usually HIV-related.

Of the 50% who do get a PCR at the under-five clinic, more than two-thirds do not return for the results or enrol into care.

Given this situation, there is a need for alternative early-infant-diagnosis entry points, note the authors. Integration of early infant diagnosis programming, they add, into a site used routinely by children and which could easily absorb an additional service, makes the most sense.

Immunisation clinics see over 90% of all Malawian children, most of whom do not have acute illnesses. This would suggest immunisation clinics are ideal sites for early infant diagnosis.

While under-five clinics offer care for sick children and provide immunisation and early infant diagnosis, the latter two are separate. Testing usually takes place at an under-five clinic only when the children are brought in for PCR testing or are sick.

So the authors chose to compare the acceptability, feasibility and outcomes of a pilot programme integrating early infant diagnostic testing into an immunisation clinic, compared to the current standard of early infant diagnostic testing at an under-five clinic.

Routine provider-initiated testing and counselling registers were used to prospectively look at 1757 children, all offered PCR testing at either the immunisation clinic at Bwaila Hospital or the under-five clinic at Kamuzu Central Hospital, beginning in February 2011. Both are busy government paediatric clinics serving a population of 750,000. Most care received is by self-referral.

The children were followed until disclosure of the PCR test result or the missed appointment at which the diagnosis should have been given. In line with the Malawian early-infant-diagnosis protocol, disclosure was set up four weeks after testing. However, for this study, two additional weeks were allowed if the appointment was missed.

The immunisation clinic pilot programme began in January 2011, while the under-five clinic offered these services from June 2010. Both clinics are open Monday to Friday, with similar staffing levels, and use volunteer patient escorts. These escorts are parents of HIV-infected children, who provide advocacy and administrative help, and accompany caregivers from the testing room to the HIV clinic for those newly identified as HIV-exposed or HIV-infected. For infants older than six weeks of age, cotrimoxazole prophylaxis is prescribed. 

Children were eligible for PCR testing if younger than 12 months of age, if they had an HIV-infected mother, and if they were not already enrolled in HIV care elsewhere.

HIV-exposed infants were defined as those younger than 12 months of age, with an HIV-infected mother and without a definitive negative PCR result, regardless of current breastfeeding status.

HIV-infected infants were defined as those older than 12 months of age who had tested HIV-antibody positive, or who had a documented positive PCR result, irrespective of their age.

During the study, 84.2% and 11.4% respectively (p<0.001) of the 880 and 877 of infants attending the immunisation clinic and the under-five clinic received provider-initiated testing and counselling.

Even though staffing levels were similar at the clinics, there is a striking difference in the numbers offered testing. Infants at the under-five clinic are often sicker and need multiple services. The higher patient volume (171 a day, compared to 52 patients per day at the immunisation clinic) contributed to the difficulties of HIV testing within this setting, making the immunisation clinic a more suitable clinic setting for early infant diagnosis.

While there were no differences according to gender at the two clinics, those getting provider-initiated counselling and testing at the immunisation clinic were over 14 months younger (2.6 compared to 17 months, p<0.001), with a greater proportion identified as HIV-exposed (17.6% compared to 5.3%, p<0.001) and PCR eligible (7.9% compared to 3.5%, p<0.001).

More carers at the immunisation clinic than at the under-five clinic accepted PCR testing for their infants (100% compared to 90.3%, p=0.03). The children were 2.5 months younger (3.1 compared to 5.6 months, p<0.001), with four times fewer testing PCR positive (7.1% compared to 32.1%, p<0.001). In addition, higher proportions had received prevention of mother-to-child (PMTCT) interventions (85.7% compared to 40%, p<0.001).

Critical to the success of early infant diagnosis programmes is being able to identify all HIV-exposed infants as young as possible so they can get the most out of access to PCR testing, PMTCT interventions, breastfeeding counselling and cotrimoxazole prophylaxis.

Likewise, early identification of HIV-infected infants and early ART is critical to maximising their chances of survival.

In all settings, but especially in resource-poor settings where severe financial, human and logistical constraints are often prevalent, effectively targeting those who will benefit the most makes the best use of expensive early-infant-diagnosis resources.

These findings, note the authors, show that provider-initiated testing and counselling at immunisation clinics, compared to under-five clinics, is a better use of resources.

The authors note these findings support those of a South African study showing similar acceptance rates of early infect diagnosis (EID) at immunisation clinics, suggesting “the integration of EID services and ICs would be acceptable throughout the southern Africa region”.

A limitation to this research is that this study only compares two urban clinics.

In conclusion, the authors “recommend the integration of opt-out HIV testing and counselling at ICs [immunisation clinics] for all eligible mothers and infants. Scaling up EID testing at ICs is likely to strengthen EID services in Malawi”.


McCollum ED et al.  Superior uptake and outcomes of early infant diagnosis of HIV services at an immunization clinic versus an “under-five” general pediatric clinic in Malawi, advance online edition J Acquir Immune Defic Syndr, doi: 10.1097/QAI.0b013e312825aa721, 2012.