Circumcising Men With HIV Did Not Protect Women, Trial Stopped Early

Early results of a trial in Uganda showed that circumcising men with HIV did not protect their female partners, and as circumcision does not benefit men who already have HIV the trial was stopped early to avoid further risk to the female participants.

The study is published in The Lancet and was conducted by lead and corresponding author Professor Maria Wawer of the Department of Population, Family and Reproductive Health at Johns Hopkins University, Bloomberg School of Public Health in Baltimore, Maryland, USA, and colleagues.

The researchers conducted the unblinded, randomized controlled trial, which took place in Rakai District, Uganda, because observation studies have concluded that there is a link between male circumcision and reduced risk of HIV infection in female sexual partners.

For the trial the researchers enrolled 922 uncircumcised HIV-infected men who were aged between 15 and 49. The men showed no symptoms and their CD4 cell count was at 350 cells per microlitre or more.

CD4 cells are helper white blood cells that lead attack against infection. After being infected with HIV for a long time a, person’s CD4 count goes down, showing that the immune system is starting to struggle in its fight against a whole range of other infections.

The men were randomly assigned to receive circumcision either immediately (474 intervention subjects), or 24 months later (448 controls).

The researchers also enrolled the female partners who tested negative for HIV at the start of the study and then tested them again after 6, 12 and 24 months.

Only 92 couples in the intervention group and 67 couples in the control group were included in the analysis, which showed that:

  • 17 (18 per cent) of women in the intervention group acquired HIV during follow up.
  • 8 per cent of women in the control group acquired HIV during follow up.
  • The cumulative probabilty of a woman being infected at 12 months was 21.7 per cent in the intervention group and 13.4 per cent in the control group.

Explaining the higher rate of infection in the intervention group, the researchers suggested it could be because the couples resumed sexual relations before the circumcision wound had fully healed.

The trial ended early “because of futility” wrote the researchers, who concluded that:

“Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention.”

The researchers said all men should still be continue to be offered circumcision on an equal basis and not offering it to men with HIV might stigmatize them.

They also wrote that the study suggests:

“Strict adherence to sexual abstinence during wound healing, and continuous condom use thereafter must be strongly promoted when HIV-infected men receive circumcision.”

They recommended that male babies and young boys be circumcised as a soon as possible, while respecting the need for consent by parents and the children themselves.

The study was supported by funds from the Bill & Melinda Gates Foundation with laboratory and training support from the National Institutes of Health and the Fogarty International Center.