5 ms·

It seems like a really scary gamble to have unprotected sex with someone who is HIV-positive for a research study, and I was wondering how the study found such

It seems like a really scary gamble to have unprotected sex with someone who is HIV-positive for a research study, and I was wondering how the study found such couples. The paper mentions that they identified couples with one HIV-positive partner, and then followed up with them to see if they reported condomless sex.

mattkrause 7y ago
Randomizing people to have sex with an HIV+ or placebo partner would bring down the IRB's wrath quite quickly. For that reason, a lot of this stuff is done observationally, where you just track people doing whatever they were going to do anyway. The data is often not as clean as a randomized controlled trial, but it seems much more ethical. An earlier trial (HPTN 052) did actually run a RCT, but the treatment strategy was randomized, not the partner. It worked so well that the trial was actually stopped early and everyone was offered antivirals. Cohen et al. (2011) reported the results here: https://www.nejm.org/doi/10.1056/NEJMoa1105243?url_ver=Z39.88-2003 https://www.nejm.org/doi/10.1056/NEJMoa1105243?url_ver=Z39.8...
- Fomite 7y ago
  You can get near to an RCT with newer trial designs like stepped-wedge designs, which are way better in terms of equipoise and nearly as efficient statistically.
  - mattkrause 7y ago
    Those are still interventional though, right? (I probably should have written observational vs. interventional instead of obs. vs RCT).
    - Fomite 7y ago
      Yep. The stepped-wedge design, for example, is one where everyone will get the intervention, but the time in which they get it is randomized.
Fomite 7y ago
Sero-discordant couples (one partner is HIV+) are fairly common - it's not asking people to do this, its asking some of those people to take a drug while they do it.
jkxyz 7y ago
I participated in the study along with my former partner. IIRC, I was asked at a health check-up if I knew my partner's status, and then asked if we wanted to enroll. It just involved meeting a (very kind) doctor every 6 months, getting a finger-prick test, and completing a form with the number of occurrences of unprotected sex. We did this for at least a year, so I hope the data were eligible.
MaupitiBlue 7y ago
These people exemplify unhealthy and pathological decision-making. It probably wasn’t that hard.

mattkrause 7y ago

Randomizing people to have sex with an HIV+ or placebo partner would bring down the IRB's wrath quite quickly. For that reason, a lot of this stuff is done observationally, where you just track people doing whatever they were going to do anyway. The data is often not as clean as a randomized controlled trial, but it seems much more ethical. An earlier trial (HPTN 052) did actually run a RCT, but the treatment strategy was randomized, not the partner. It worked so well that the trial was actually stopped early and everyone was offered antivirals. Cohen et al. (2011) reported the results here: https://www.nejm.org/doi/10.1056/NEJMoa1105243?url_ver=Z39.88-2003 https://www.nejm.org/doi/10.1056/NEJMoa1105243?url_ver=Z39.8...

Fomite 7y ago
You can get near to an RCT with newer trial designs like stepped-wedge designs, which are way better in terms of equipoise and nearly as efficient statistically.
- mattkrause 7y ago
  Those are still interventional though, right? (I probably should have written observational vs. interventional instead of obs. vs RCT).
  - Fomite 7y ago
    Yep. The stepped-wedge design, for example, is one where everyone will get the intervention, but the time in which they get it is randomized.

Fomite 7y ago

Sero-discordant couples (one partner is HIV+) are fairly common - it's not asking people to do this, its asking some of those people to take a drug while they do it.

jkxyz 7y ago

I participated in the study along with my former partner. IIRC, I was asked at a health check-up if I knew my partner's status, and then asked if we wanted to enroll. It just involved meeting a (very kind) doctor every 6 months, getting a finger-prick test, and completing a form with the number of occurrences of unprotected sex. We did this for at least a year, so I hope the data were eligible.

MaupitiBlue 7y ago

These people exemplify unhealthy and pathological decision-making. It probably wasn’t that hard.